Volume 5, Issue 4,
Pages no. 334-409
ISSN 2277-3681
Available online on 01 July 2015
J Pharm Sci Bioscientific Res. 2015; 5(4):334-409.
Copyright © 2014 JPSBR Publications
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ABSTRACT:
The purpose of this research study to develop a novel, simple, precise, accurate and economical method for determination of methyl
camphor sulfonate by derivatization with 2,4- DNPH in clopidogrel hydrogen sulphate. Chromatographic analysis was performed on
Phenomenex Synergi Hydro (250 × 4.6 mm, 5 ?m) Column. Mobile phase (a) was 5mL perchloric acid in 1000 mL water and mobile phase
(b) was a mixture of acetonitrile and methanol in the ratio of 75:25. A initial linear gradient proportion of mobile phase (a) and mobile phase
(b) was in 50:50 for 8 min, 20:80 for 12 min then 5:95 for 18 min followed by 20:80 for 20 min and finally in original composition 50:50 for
25min and 30 min. The Flow rate kept for throughout analysis was 1.0 mL min-1 and chromatographic elution was monitored by waters 2489
UV/visible detector. The peak detection was done at 360 nm wavelength. This method allows for detection of methyl camphor sulfonate at
0.315 ?g/mL and 0.954 ?g/mL for quantification respectively. The linear response was found in a concentration range of 0.97-30.27 ?g/mL
with a squared correlation coefficient was 1.0000. The mean recovery was found to be 101.9%. Hence the developed method was simple,
fast, linear, accurate and reproducible. The same method was validated by following ICH guidelines.
KEY WORDS: HPLC; Methyl camphor sulfonate; 2, 4-Dinitrophenylhydrazine (2, 4- DNPH); C18, Synergi Hydro
The purpose of this research study to develop a novel, simple, precise, accurate and economical method for determination of methyl
camphor sulfonate by derivatization with 2,4- DNPH in clopidogrel hydrogen sulphate. Chromatographic analysis was performed on
Phenomenex Synergi Hydro (250 × 4.6 mm, 5 ?m) Column. Mobile phase (a) was 5mL perchloric acid in 1000 mL water and mobile phase
(b) was a mixture of acetonitrile and methanol in the ratio of 75:25. A initial linear gradient proportion of mobile phase (a) and mobile phase
(b) was in 50:50 for 8 min, 20:80 for 12 min then 5:95 for 18 min followed by 20:80 for 20 min and finally in original composition 50:50 for
25min and 30 min. The Flow rate kept for throughout analysis was 1.0 mL min-1 and chromatographic elution was monitored by waters 2489
UV/visible detector. The peak detection was done at 360 nm wavelength. This method allows for detection of methyl camphor sulfonate at
0.315 ?g/mL and 0.954 ?g/mL for quantification respectively. The linear response was found in a concentration range of 0.97-30.27 ?g/mL
with a squared correlation coefficient was 1.0000. The mean recovery was found to be 101.9%. Hence the developed method was simple,
fast, linear, accurate and reproducible. The same method was validated by following ICH guidelines.
KEY WORDS: HPLC; Methyl camphor sulfonate; 2, 4-Dinitrophenylhydrazine (2, 4- DNPH); C18, Synergi Hydro
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ABSTRACT:
Khadirarishta is a polyherbal fermented Ayurvedic medicine. It is mainly made out by heart wood of Acacia catechu along with other herbal
ingredients. Khadirarishta is the best remedy for skin diseases and almost all the stress related problems are resolved in an Ayurvedic natural
way, thus giving no side effects. Khadirarishta sample was procured from Ayurvedic Rasashala, Karve Road, Pune. It was tested for its anti-lipid
peroxidation with human erythrocytes along estimation of phytoconstituents like phenol, flavonoid, tannic acid, gallic acid and ascorbic acid.
The lipid peroxidation was induced with hydrogen peroxide (H2O2) in an in-vitro human erythrocyte model. Results indicate that khadirarishta
has good antioxidant potential and reduces lipid peroxidation in human erythrocytes.
KEY WORDS: Khadirarishta, Lipid peroxidation, Erythrocytes, Phytoconstituents
Khadirarishta is a polyherbal fermented Ayurvedic medicine. It is mainly made out by heart wood of Acacia catechu along with other herbal
ingredients. Khadirarishta is the best remedy for skin diseases and almost all the stress related problems are resolved in an Ayurvedic natural
way, thus giving no side effects. Khadirarishta sample was procured from Ayurvedic Rasashala, Karve Road, Pune. It was tested for its anti-lipid
peroxidation with human erythrocytes along estimation of phytoconstituents like phenol, flavonoid, tannic acid, gallic acid and ascorbic acid.
The lipid peroxidation was induced with hydrogen peroxide (H2O2) in an in-vitro human erythrocyte model. Results indicate that khadirarishta
has good antioxidant potential and reduces lipid peroxidation in human erythrocytes.
KEY WORDS: Khadirarishta, Lipid peroxidation, Erythrocytes, Phytoconstituents
ABSTRACT:
Background: The physiological changes that occur in pregnancy challenge both health care providers and pregnant women managing disease
states during pregnancy using medications given the fear of teratogenic effects and the potential for fetal harm.
Objectives: To assess drug prescribing pattern among pregnant women attending antenatal care in health centers in Arada subcity, Addis
Ababa. Methods: A retrospective cross sectional descriptive study was carried out on pregnant women who attended the antenatal clinics of
health centers from June 2012 until March 2013, using the information gained from antenatal care follow-up cards by using data abstraction
format. Results: The study was done by enrolling 314 pregnant women among whom 299 (95.2%) pregnant women used at least one drug
during their pregnancy including iron/folic acid combination (excluding vaccination) and forty two different drugs were prescribed during all
pregnancy stages. The most commonly used drugs were vitamin/mineral supplements, antibiotics, analgesics, and gastrointestinal drugs. A
high proportion of drugs were prescribed from US FDA category A, followed by category B and C. A small percentage of drugs 2.44% and
5.09% were prescribed from drugs with positive evidence of risk (US FDA category D) during second and third trimesters, respectively. No
drugs from proven fetal risk (US FDA category X) were prescribed. Conclusion/recommendation: A considerable proportion of pregnant
women were exposed to drug, including those with Positive evidence of risk to the fetus, during pregnancy. Health care providers should
weigh the therapeutic benefits of the drugs to the mother against its potential to the developing fetus before prescribing.
KEYWORDS: Pregnancy women, prescription, drug use, Arada subcity.
Background: The physiological changes that occur in pregnancy challenge both health care providers and pregnant women managing disease
states during pregnancy using medications given the fear of teratogenic effects and the potential for fetal harm.
Objectives: To assess drug prescribing pattern among pregnant women attending antenatal care in health centers in Arada subcity, Addis
Ababa. Methods: A retrospective cross sectional descriptive study was carried out on pregnant women who attended the antenatal clinics of
health centers from June 2012 until March 2013, using the information gained from antenatal care follow-up cards by using data abstraction
format. Results: The study was done by enrolling 314 pregnant women among whom 299 (95.2%) pregnant women used at least one drug
during their pregnancy including iron/folic acid combination (excluding vaccination) and forty two different drugs were prescribed during all
pregnancy stages. The most commonly used drugs were vitamin/mineral supplements, antibiotics, analgesics, and gastrointestinal drugs. A
high proportion of drugs were prescribed from US FDA category A, followed by category B and C. A small percentage of drugs 2.44% and
5.09% were prescribed from drugs with positive evidence of risk (US FDA category D) during second and third trimesters, respectively. No
drugs from proven fetal risk (US FDA category X) were prescribed. Conclusion/recommendation: A considerable proportion of pregnant
women were exposed to drug, including those with Positive evidence of risk to the fetus, during pregnancy. Health care providers should
weigh the therapeutic benefits of the drugs to the mother against its potential to the developing fetus before prescribing.
KEYWORDS: Pregnancy women, prescription, drug use, Arada subcity.
ABSTRACT:
The SeDeM system is a useful tool for the galenic characterization of excipients with respect to their suitability for direct compression. It
provide an index of good compressibility (ICG) of material indicating its aptitude to be compressed by direct compression Different excipients
were analysed by experimental studies of SeDeM parameters and graphical expression (SeDeM Diagram) to determine whether they were
suitable for direct compression. Mathematical equation and properties of excipients were used to identify the best excipient and the optimum
amount to be used in the formulation. The results confirm that the SeDeM method is effective tool for development of tablets by direct
compression. The application of SeDeM expert system enables selecting excipients with in order to optimize the formula in the preformulation
and formulation studies.
KEY WORDS: SeDeM Expert system, Direct Compression, Bulk Density (Da), Tapped Density (Dc), Interparticle Porosity (Ie), Carr Index(IC),
Angle of Repose
The SeDeM system is a useful tool for the galenic characterization of excipients with respect to their suitability for direct compression. It
provide an index of good compressibility (ICG) of material indicating its aptitude to be compressed by direct compression Different excipients
were analysed by experimental studies of SeDeM parameters and graphical expression (SeDeM Diagram) to determine whether they were
suitable for direct compression. Mathematical equation and properties of excipients were used to identify the best excipient and the optimum
amount to be used in the formulation. The results confirm that the SeDeM method is effective tool for development of tablets by direct
compression. The application of SeDeM expert system enables selecting excipients with in order to optimize the formula in the preformulation
and formulation studies.
KEY WORDS: SeDeM Expert system, Direct Compression, Bulk Density (Da), Tapped Density (Dc), Interparticle Porosity (Ie), Carr Index(IC),
Angle of Repose
ABSTRACT:
Diabetes Mellitus is a chronic debilitating condition which has affected more than 150 million people worldwide and this number is increasing
rapidly. In 2000 32 million people are affected with DM in India and India is leading the world with this number. Diabetes is a condition which, if
not controlled adequately may result in serious complications. Pharmaceutical care is a practice in which the practitioner takes responsibility for
a patient's drug-related needs and is held accountable for this commitment. Patient counseling is the process of providing information, advice
and assistance to help patients use their medications appropriately. The information and advice is given by the pharmacist directly to patient or
to patient's representative which is not only limited to medications, it also includes information about patient's illness, or life-style changes
recommendations. The information is usually given verbally, but it may be aided with a written material as well. The literature review of the year
2008 to 2013 revealed that many published articles give the evidences that pharmaceutical care programs relating to patient counseling
including the information on disease, drugs and life-style modifications such as food, self-care, exercise, etc. reduces the glycemic indices of
diabetic patients. This results in better care of patients with chronic disease and helps them improving their daily living with diseases. Counseling
helps achieving the personalized therapeutic goal of each individual patient. Evidences suggest that integrated pharmaceutical care by clinical
pharmacist results in reduction of glycemic control of diabetic patients.
KEYWORDS: Glycemic Control, Clinical Pharmacist, Patient Counseling, Pharmaceutical Care, Diabetic Patients, Glycated Hemoglobin, India.
Diabetes Mellitus is a chronic debilitating condition which has affected more than 150 million people worldwide and this number is increasing
rapidly. In 2000 32 million people are affected with DM in India and India is leading the world with this number. Diabetes is a condition which, if
not controlled adequately may result in serious complications. Pharmaceutical care is a practice in which the practitioner takes responsibility for
a patient's drug-related needs and is held accountable for this commitment. Patient counseling is the process of providing information, advice
and assistance to help patients use their medications appropriately. The information and advice is given by the pharmacist directly to patient or
to patient's representative which is not only limited to medications, it also includes information about patient's illness, or life-style changes
recommendations. The information is usually given verbally, but it may be aided with a written material as well. The literature review of the year
2008 to 2013 revealed that many published articles give the evidences that pharmaceutical care programs relating to patient counseling
including the information on disease, drugs and life-style modifications such as food, self-care, exercise, etc. reduces the glycemic indices of
diabetic patients. This results in better care of patients with chronic disease and helps them improving their daily living with diseases. Counseling
helps achieving the personalized therapeutic goal of each individual patient. Evidences suggest that integrated pharmaceutical care by clinical
pharmacist results in reduction of glycemic control of diabetic patients.
KEYWORDS: Glycemic Control, Clinical Pharmacist, Patient Counseling, Pharmaceutical Care, Diabetic Patients, Glycated Hemoglobin, India.
ABSTRACT:
A newer, simple, rapid, accurate, precise and sensitive method was developed and validated for determination of Loteprednol Etabonate
(LOTE) and Tobramycin (TOBRA) in combined dosage form. The method employed was First order derivative. Concentration range of 15-35
µg/ml for Loteprednol Etabonate and 9-21 µg/ml for Tobramycin for the proposed method. First order Derivative method, wherein
wavelengths selected were 223.62nm( ZCP of Tobramycin) for Loteprednol Etabonate and 300 nm(ZCP of Loteprednol) for Tobramycin. The
results of the analysis were analyzed and validated statistically and recovery study was carried out as per ICH guidelines.
KEYWORDS: Loteprednol Etabonate (LOTE) and Tobramycin (TOBRA), First Order derivative method, ZCP (Zero Cross point)
A newer, simple, rapid, accurate, precise and sensitive method was developed and validated for determination of Loteprednol Etabonate
(LOTE) and Tobramycin (TOBRA) in combined dosage form. The method employed was First order derivative. Concentration range of 15-35
µg/ml for Loteprednol Etabonate and 9-21 µg/ml for Tobramycin for the proposed method. First order Derivative method, wherein
wavelengths selected were 223.62nm( ZCP of Tobramycin) for Loteprednol Etabonate and 300 nm(ZCP of Loteprednol) for Tobramycin. The
results of the analysis were analyzed and validated statistically and recovery study was carried out as per ICH guidelines.
KEYWORDS: Loteprednol Etabonate (LOTE) and Tobramycin (TOBRA), First Order derivative method, ZCP (Zero Cross point)
ABSTRACT
Now a day's number of new drug molecules developed, but about 40% of new drug candidates identified by chemical screening as poorly water
solubility and low bioavailability. There is a need to develop a drug delivery system which overcome these problems. As an alternative system to
emulsion, liposomes and polymeric micro particulate systems, Lipid nanoparticles (Solid lipid nanoparticles (SLN) and Nanostructured lipid
carrier (NLC)) has developed due to their own limitations. SLN gained lot of popularity among researcher due to its applicability for various
routes such as oral, Parenteral, topical and also the properties of site specific and controlled drug delivery with reduced side effects. Along with
their advantages, some challenges such as low drug loading and drug expulsion from SLN during storage. These limitations were overcome in
Nanostructured lipid carriers (NLC), which are second generation the new type of Lipid nanoparticles, based on mixture of solid lipids with
spatially incompatible liquid which offer the advantage of improved drug loading capacity and release properties of poorly soluble drug mainly due
their imperfect or unordedred structure. They may increase, bioavailability and stability of bioactive compounds, and shelf-life, functionality,
consumer acceptability, nutritional value and safety of food systems, and provide controlled release of encapsulated materials.
KEYWORDS: NLC, SLN, melt emulsification method, solvent diffusion method, high pressure hot homogenization, solid lipid, liquid lipid (oil),
surfactant, solubility, sustain release, imperfection, encapsulation efficiency, particle size
Now a day's number of new drug molecules developed, but about 40% of new drug candidates identified by chemical screening as poorly water
solubility and low bioavailability. There is a need to develop a drug delivery system which overcome these problems. As an alternative system to
emulsion, liposomes and polymeric micro particulate systems, Lipid nanoparticles (Solid lipid nanoparticles (SLN) and Nanostructured lipid
carrier (NLC)) has developed due to their own limitations. SLN gained lot of popularity among researcher due to its applicability for various
routes such as oral, Parenteral, topical and also the properties of site specific and controlled drug delivery with reduced side effects. Along with
their advantages, some challenges such as low drug loading and drug expulsion from SLN during storage. These limitations were overcome in
Nanostructured lipid carriers (NLC), which are second generation the new type of Lipid nanoparticles, based on mixture of solid lipids with
spatially incompatible liquid which offer the advantage of improved drug loading capacity and release properties of poorly soluble drug mainly due
their imperfect or unordedred structure. They may increase, bioavailability and stability of bioactive compounds, and shelf-life, functionality,
consumer acceptability, nutritional value and safety of food systems, and provide controlled release of encapsulated materials.
KEYWORDS: NLC, SLN, melt emulsification method, solvent diffusion method, high pressure hot homogenization, solid lipid, liquid lipid (oil),
surfactant, solubility, sustain release, imperfection, encapsulation efficiency, particle size
ABSTRACT:
A reversed-phase liquid chromatographic method has been developed and validated for estimation of Gresiofulvin in Tablet dosage form.
Chromatography was carried on Spherisorb CN (250 x 4.6) mm; 5µm) analytical column using mobile phase ACN : 5% THF IN WATER (30:70)
at a flow rate of 01.0 ml/min. The detection was carried out at 293 nm. The retention time of Gresiofulvin is found to be 3.760. Correlation co-
efficient for Gresiofulvin was found to be 0.999. Assay result of marketed formulation was found to be in 101.04%. The proposed method was
validated with respect to linearity, accuracy, precision, selectivity, and robustness. Recovery was found in the range of 98.09 %- 98.67 %.
Statistical Analysis proves that the developed methods were successfully applied for the analysis of pharmaceutical formulations and can be
used for routine analysis of drugs in Quality Control laboratories.
KEY-WORDS: Gresiofulvin, RP-HPLC, Mobile phase, Validation, Analytical method development
A reversed-phase liquid chromatographic method has been developed and validated for estimation of Gresiofulvin in Tablet dosage form.
Chromatography was carried on Spherisorb CN (250 x 4.6) mm; 5µm) analytical column using mobile phase ACN : 5% THF IN WATER (30:70)
at a flow rate of 01.0 ml/min. The detection was carried out at 293 nm. The retention time of Gresiofulvin is found to be 3.760. Correlation co-
efficient for Gresiofulvin was found to be 0.999. Assay result of marketed formulation was found to be in 101.04%. The proposed method was
validated with respect to linearity, accuracy, precision, selectivity, and robustness. Recovery was found in the range of 98.09 %- 98.67 %.
Statistical Analysis proves that the developed methods were successfully applied for the analysis of pharmaceutical formulations and can be
used for routine analysis of drugs in Quality Control laboratories.
KEY-WORDS: Gresiofulvin, RP-HPLC, Mobile phase, Validation, Analytical method development
ABSTRACT:
When bacterial diagnosis is considered with its antibiotic profiles, it can do wonders in preventing antibiotic resistance. This of course will
help clinicians to write accurate, right and complete prescription without need of broad spectrum or antibiotic combination therapy. This is the
only policy that is very simple and that very effective with no big limitations to reduce antibiotic resistance along with Multi drug resistance.
Used for disease prevention and infection control procedures this data can be used to protect people now and in future. A total number of 908
clinical samples i.e., urine, blood, pus, other body fluids were collected in the laboratory in the period of two years. The samples were
streaked on various culture media for bacterial growth and incubated at 37oC for 24 hours. The plates of the agar media were observed after
24 hours of incubation to identify the types and number of colonies. The plates that were showing no growth were reincubated for next 24 hrs
before confirming them as sterile. The results were variable with various types of pathogens in different clinical samples. E.coli was found to
be the main causative agent in almost clinical infections.
KEY WORDS: antibiotic susceptibility, antimicrobial resistance surveillance, isolation, clinical samples
When bacterial diagnosis is considered with its antibiotic profiles, it can do wonders in preventing antibiotic resistance. This of course will
help clinicians to write accurate, right and complete prescription without need of broad spectrum or antibiotic combination therapy. This is the
only policy that is very simple and that very effective with no big limitations to reduce antibiotic resistance along with Multi drug resistance.
Used for disease prevention and infection control procedures this data can be used to protect people now and in future. A total number of 908
clinical samples i.e., urine, blood, pus, other body fluids were collected in the laboratory in the period of two years. The samples were
streaked on various culture media for bacterial growth and incubated at 37oC for 24 hours. The plates of the agar media were observed after
24 hours of incubation to identify the types and number of colonies. The plates that were showing no growth were reincubated for next 24 hrs
before confirming them as sterile. The results were variable with various types of pathogens in different clinical samples. E.coli was found to
be the main causative agent in almost clinical infections.
KEY WORDS: antibiotic susceptibility, antimicrobial resistance surveillance, isolation, clinical samples
ABSTRACT:
Nanoparticles have emerged as a next-generation drug delivery system with potential applications in pharmaceutical field, cosmetics,
research, clinical medication and alternative allied sciences. Recently, increasing attention has been targeted on these SLN as mixture drug
carriers for incorporating deliquescent or lipotropic medication. Proteins and antigens supposed for therapeutic functions could also be
incorporated or adsorbate onto SLN, and more administered by epithelial duct routes or be various routes like oral, nasal and respiratory
organ. The biodegradable and bioacceptable nature of SLNs makes them less cytotoxic as compared to polymeric nanoparticles. Chitosan is
one in all the biodegradable and bioacceptable polymer. Chitosan could be a natural polysaccharide ready by the N-DE acylation of chitin.
Chitosan is a remarkable polymer that has been used extensively within the medical field. It's either partly or absolutely deacetylated
polysaccharide. Chitosan could be an absolutely biodegradable and biocompatible natural chemical compound, and might be used as an
adhesive and as an antibacterial and antimycotic agent. Chitosan is soluble in acidic conditions - in solution the free amino teams on its
polymeric chains will protonate, giving it a positive charge. Chitosan nanoparticles is fashioned by incorporating a poly anion like
tripolyphosphate (TPP) into a chitosan solution beneath constant stirring.
KEYWORDS: Chitosan, Nanoparticles, Biodegradable, SLNs, Polymeric nanoparticles, chitin
Nanoparticles have emerged as a next-generation drug delivery system with potential applications in pharmaceutical field, cosmetics,
research, clinical medication and alternative allied sciences. Recently, increasing attention has been targeted on these SLN as mixture drug
carriers for incorporating deliquescent or lipotropic medication. Proteins and antigens supposed for therapeutic functions could also be
incorporated or adsorbate onto SLN, and more administered by epithelial duct routes or be various routes like oral, nasal and respiratory
organ. The biodegradable and bioacceptable nature of SLNs makes them less cytotoxic as compared to polymeric nanoparticles. Chitosan is
one in all the biodegradable and bioacceptable polymer. Chitosan could be a natural polysaccharide ready by the N-DE acylation of chitin.
Chitosan is a remarkable polymer that has been used extensively within the medical field. It's either partly or absolutely deacetylated
polysaccharide. Chitosan could be an absolutely biodegradable and biocompatible natural chemical compound, and might be used as an
adhesive and as an antibacterial and antimycotic agent. Chitosan is soluble in acidic conditions - in solution the free amino teams on its
polymeric chains will protonate, giving it a positive charge. Chitosan nanoparticles is fashioned by incorporating a poly anion like
tripolyphosphate (TPP) into a chitosan solution beneath constant stirring.
KEYWORDS: Chitosan, Nanoparticles, Biodegradable, SLNs, Polymeric nanoparticles, chitin
