Stability Indicating HPLC Method Development and Validation for Simultaneous Estimation of Ketoprofen and
Thiocolchicoside in Combined Solid Oral Dosage Form
Ankita Bhavsar, Toral Joshi, Kartik Vikani
Spherical Agglomeration: A Novel Particle Design Technique to Improve Micromeritic and Dissolution Properties
Suryabali K. Yadav, Abhirajsinh J. Solanki, Jitendra J. Jaiswal
Volume 6, Issue 4, Pages no. 461-593 , ISSN 2277-3681
Available online on 1 July 2016
J Pharm Sci Bioscientific Res. 2016; 6(4):461-593
Formulation and Evaluation of Floating Tablets of Labetalol Hydrochloride
Subhash Kumar V, Saranya Nair P*, Hitesh Vekariya
Synthesis and Characterization of Novel 4-(4-(4-(4-Methoxyphenoxy) Phenoxy) Phenyl)-6-Phenylpyrimidine 2-Amine
and their Biological Evaluation
Mikita K. Shah, Kartik B. Vyas, Rajiv A. Shah, G. R. Jani, Kiran S Nimavat
Role of Flavonoids and Saponins in the Treatment of Diabetes Mellitus
Neha Lavle, Priyanka Shukla, Aashish Panchal
Development and Validation of Stability Indicating Analytical Method for Simultaneous Estimation of Perindopril
and Losartan Potassium in Their Combined Marketed Dosage Form
Gurjeet Kaur*, Nikhil Patel Mandev B, Patel, Bhumika D. Sakhreliya
Development and Validation of Analytical Methods for Simultaneous Estimation of Pregabalin and Amitriptyline
Hydrochloride in their Combined Marketed Dosage form
Nikhilkumar Patel, Gurjit Kaur, Patel Mandev B. Bhumika D. Sakhreliya
Copyright © 2014 JPSBR Publications
Powered by Opus
Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Prednisolone Acetate
and Ofloxacin in its Pharmaceutical
Parekh Akshita S., Smita Joshi
Enhancement of Solubility of Poorly Solubile Drug Tinidazole
Harshil Shah, Hardeep Banwait, Nishith Patel
Synthesis and Characterization of N-(4-(N-(4-(4-(4-(4-Methoxy Phenoxy) Phenoxy) Phenyl)-6-Phenylpyrimidin-2-
YL-(Salfamoyl) Phenyl) Acetamide Derivative
Mikita K. Shah, Kartik B. Vyas, Rajiv A. Shah, Kiran S Nimavat.
Synthesis and Antibacterial Evaluation of Novel Heterocyclic Compound Containing a Testosterone Moiety
Mrunalini D Kulkarni, Vinay A Joshi
Current Indian pharmacy practice: Need for up gradation
Shah Jainam V., Patel Jolly M., Barot Rajan G., Patel Geet M., Mansuri Mustakim M., Deshpande Shrikalp S
Stability Indicating RP-HPLC Method for Estimation of Duloxetine in Tablet Dosage Form
Jinkal R. Daraji, Chiragkumar Panchal, Bhumika Sakhreliya, Mandev B. Patel
Stability Indicating HPLC Method Development and Validation for Simultaneous Estimation of Bromhexine and
Phenylephrine HCL in its Combined Pharmaceutical Dosage Form
N. P. Jivani, Hitesh Vekariya, Hetal P. Rajput*
Formulation and Evaluation of Topical Herbal Cream for Cellulitis
Harshal Sheth*, Sharav Desai, Dhara Patel,Dhruvi Patel,Priyanka Patel,Snehal Patel,Kartik Pandya, Chainesh Shah
ABSTRACT:
A new stability-indicating reversed-phase high-performance liquid chromatographic method for the analysis of Ketoprofen and
Thiocolchicoside was developed and validated. The column used was Phenomex - C18 (150 × 4.6 mm, 5?) with flow rate of 1.0ml/min
using PDA detector at 330 nm. Methanol was used as a solvent. The chromatograms were developed using 1% Ammonium acetate and
1% acetic acid: Acetonitrile (80:20 %v/v) as a mobile phase. The described method was linear over a concentration range of 4000-6000
ppm and 320-480 ppm for the assay of Ketoprofen and Thiocolchicoside respectively. The retention times of Ketoprofen and
Thiocolchicoside were found to be 16.104 min and 5.853 min respectively. The % recovery of Ketoprofen and Thiocolchicoside was
found to be 101 % and 98.85 % respectively. The limit of detection and limit of quantification were found to be 16.37 ?g/ml and 49.62
?g/ml for Ketoprofen and for Thiocolchicoside were found to be 13.60 ?g/ml and 41.23 ?g/ml respectively. The % RSD of Ketoprofen
and Thiocolchicoside were found to be 0.09 % and 0.39 % respectively. The method developed is robust. The drug was exposed to
acidic, basic, oxidative, photolytic and thermal degradation. The peaks of degradation products were well-resolved from the peak of the
standard drug with significantly different values. Results showed that the developed method is simple, specific, accurate and robust for
the determination of Ketoprofen and Thiocolchicoside in its formulation. The method can effectively separate the drug from its
degradation products and it can be considered as stability-indicating assay.
Key words: Ketoprofen, Thiocolchicoside, Acetonitrile, Method Development, Validation, Stability study, Methanol
![[x]](JPSBR_Vol_6_Issue_1_htm_files/close.png "Close")
ABSTRACT:
Tablet is most popular solid oral dosage form. It boosts stability, portability and acceptable patient compliance. The quality of solid oral
dosage form is primarily affected by poor micromeritic properties such as size, shape, flowability, compressibility of drug crystal, mostly in
case of poorly water soluble drugs. The poor flow property and compressibility give rise difficulty in pharmaceutical preparation meant for
oral use and the poor aqueous solubility limits its effective absorption and bioavailability. Spherical agglomeration of drug particle induce
spherical shape, enlarge the size, improve porosity and improve wettability, which in turn improve the dissolution and micromeritic properties
like flow property and compressibility of drug. The resulting spherically agglomerated crystals can be directly compressed into a tablet, thus
direct tabletting saves time and reduces cost.
KEYWORDS: Spherical crystallization, agglomerates, flowability, direct compression, Solubility, Dissolution rate.
ABSTRACT:
Labetalol HCl is mainly used in the treatment of hypertension. The characteristic of the drug is it has short half life (3-6 hrs)
and undergoes first pass metabolism.It is PH dependent with solubility range of 6-10. This research work was carried out to
improve the bioavailability, patient compliance & solubility on oral floating drug of Labetalol HCl. 300mg of Labetalol HCl
sustained controlled release tablets were formulated by wet granulation method and in vitro dissolution studies were
performed to study drug release rate and patterns. HPC, HEC, Xanthum gum were used as rate controlling polymers. Tablets
were prepared using different polymer ratios. Dissolution profiles are determined using USP XXII at 50 rpm in 99ml of acidic
medium (PH 1.1) for 2 hrs followed by 900 ml alkaline dissolution medium (PH 7.4) upto 12hrs. To determine the drug release
kinetics several kinetic models were applied to the dissolution profiles.
KEY WORDS: HPC ( Hydroxy propyl cellulose), HEC ( Hydroxy ethyl cellulose), GRDDS(Gastroretentive drug delivery
system), FDDS(Floating drug delivery system), GRT (Gastric retention time), GET(Gastric emptying time).
ABSTRACT:
Development And Validation Of Stability Indicating RP-HPLC Method For Estimation Duloxetine In Tablet
Dosage Form Chromatography was performed on a C-18, 150 X 4.6 mm, 5 m (Dionex), column with mobile
phase containing Water : Methanol : Acetonitrile: TEA (40:40:24:1.8) with Triethylamine (0.1%). The flow rate
was 1 ml/min and the eluent was monitored at 230 nm. The selected chromatographic conditions were found
effectively to seperate Duloxetine at 4.38 min. Linearity for Duloxetine was found in the range of 5-40 ?g/ml.
KEYWORDS: RP-HPLC, Duloxetine, Stability Indicating, Methanol,ACN, Triethylamine.
ABSTRACT:
4-(4-chlorophenoxy)-1,2-dimethylbenzene react with 1-(4-hydroxyphenyl)ethanone in presence of copper metal
as a catalyst gives 1-(4-(4-(3,4-dimethylphenoxy) -phenoxy)phenyl)ethanone,this derivatives react with various
substituted aldehyde to give corresponding substituted chalcone derivatives. Now these derivatives on
condensation with Guanidine nitrate give the vast range of phenyl pyrimidine amine Derivatives. Structure
elucidation of synthesized compound had been made on the basis of element analysis, 1H NMR Spectra
studies. The microbial activity of the synthesized compounds has been studied against the species bacillus
subtillis, staphylococcus aureus, Escherichia coli, and salmonella typhi.
KEY WORDS: Synthesis, heterocyclic substituted chalcone derivatives, Pyrimidine derivatives, Chalcon
ABSTRACT:
The synthesis of chalcones was carried out by one pot condensation of 1-chloro-(4-tolyloxy) benzene with 1-(4-hydroxylphenyl)
ethanone followed by condensation with various aromatic aldehydes. Prepared chalcones were refluxing with guanidine to yields
various pyrimidine derivatives. All the prepared compounds were characterized in by 1H NMR, 13C NMR, IR, MASS
spectroscopic techniques. Biological evaluation of mention compounds was also made in terms of gram positive bacteria such as
Staphylococcus aureus, Bacillus megaterium and gram negative bacteria Escherichia coli, Proteus vulgaris.
KEYWORDS: Pyrimidine, Chalcone, Aldehydes, Antimicrobialactivity, Guanidine, Spectroscopy
ABSTRACT:
Diabetes Mellitus (DM) is a metabolic disease characterized by hyperglycemia due to insufficient or inefficient insulin
secretory response. This chronic disease is a global problem and there is need for greater emphasis on therapeutic
strategies in the health system. Current synthetic agents and insulin used effectively for the treatment of diabetes are
expensive and have prominent adverse effects. Complementary and alternative approaches to diabetes management such
as isolation of phytochemicals with anti-hyperglycemic activities from medicinal plant are therefore imperative.
Phytochemicals such as flavonoids and saponins have recently attracted attention as source materials for the development
of new anti-diabetic drugs or alternative therapy for the management of diabetes and its related complications. This paper
emphasis on the investigations that explore the role of these compounds (flavonoids &saponins) for anti-diabetic remedy.
KEY WORDS:Hyperglycemia, flavonoids, antioxidant activity, saponins
ABSTRACT:
A simple, precise and accurate stability indicating RP-HPLC method was developed and validated for simultaneous estimation of
Perindopril and Losartan Potassium in their combined marketed dosage form. Validation parameter proves that method is
repeatable, sensitive and selective for the analysis of Perindopril and Losartan Potassium. Based on this evidence the method can
be stated as highly economical and it is recommended for routine analysis and stability studies. In this method Buffer (Potassium
Dihydrogen Phosphate): Methanol (80:20v/v) was used as a mobile phase and C18 (25cm x 0.46 cm) Hypersil BDS analytical
column was used for the separation of drug with other degraded product. The flow rate 1.0 ml/min, detection wavelength 230 nm
was used. The retention time for Perindopril and Losartan Potassium was found to be 3.867 minute and 5.287 minute. The linearity
for Perindopril and Losartan Potassium was obtained in the concentration range of 2-6 ?g/ml and 50-150 ?g/ml with accuracy of
99.59-99.88% and 99.63-99.92 %. The developed method meets all the acceptance criteria for the validation of analytical method
as per the ICH guideline. The degradation of Perindopril and Losartan Potassium in acid, base, oxidation, thermal and Photolytic
condition was found to be 23.09%, 20.27%, 24.86%, 22.06% and 21.00% and for Losartan Potassium 21.17%, 23.00%, 25.77%,
21.65% and 19.74% respectively.
Key words: Perindopril, Losartan Potassium, Stability indicating RP-HPLC, validation
ABSTRACT:
A reversed-phase liquid chromatographic method has been developed and validated for estimation of Pregabalin (PRE) and
Amitriptyline hydrochloride (AMI) in Tablet dosage form. Chromatography was carried on C18 (25cm x 0.46 cm) Hypersil BDS
analytical column using mobile phase Buffer (Potassium Dihydrogen Phosphate): Acetonitrile (55:45v/v) pH 4.0 with O-
Phosphoric acid at a flow rate of 1.0 ml/min. The detection was carried out at 210 nm. The retention time of PRE and AMI was
found to be 5.100 min and 3.227 min respectively. Assay result of marketed formulation of PRE and AMI was found to be
100.84% and 100.46% respectively. The proposed method was validated with respect to linearity, accuracy, precision, selectivity
and robustness. Recovery of PRE and AMI was found to be 100.29% and 100.33% respectively. PRE and AMI were scanned in
wavelength range of 200-400 nm. The proposed method for estimation of PRE and AMI were found to be simple, precise and
accurate is applicable for simultaneous determination of PRE and AMI in marketed tablet formulation.
KEY WORDS:Pregabalin and Amitriptyline hydrochloride, RP-HPLC, Validation
ABSTRACT:
RP-HPLC method has been developed for the estimation of Prednisolone Acetate and Ofloxacin in combined pharmaceutical dosage form. In
RP-HPLC method, Chromatographic separation was achieved using BDS Hypersil C18 (250 mm × 4.6 mm i.d. 5µm) analytical column and
Buffer Potassium Dihydrogen Phosphate, pH 6.0: Acetonitrile (70:30) as a mobile phase at a flow rate of 1.0 ml/min with detection wavelength
275 nm. Forced degradation study was carried out at a different condition using Buffer Potassium Dihydrogen Phosphate, pH 6.0: Acetonitrile
(70:30) as a mobile phase in RP-HPLC method. For RP-HPLC linearity of Ofloxacin and Prednisolone Acetate were found in the range of 10-
30 µm/ml and 3-9 µm/ml respectively. The retention time of Prednisolone Acetate and Ofloxacin are found to be 3.593& 5.263 min respectively.
In Forced Degradation Study, 24.82 % degradation and 22.18 % degradation were observed in 0.1 N HCL (4 Hours) for Ofloxacin and
Prednisolone Acetate respectively. In 0.1 N NaOH (2.5 Hours) 24.29 % degradation and 20.60 % degradation were observed for Ofloxacin and
Prednisolone Acetate respectively. 14.97 % degradation and 20.81 % degradation were observed to sunlight exposure for Ofloxacin and
Prednisolone Acetate respectively.Data revealed that the developed RP-HPLC method was found to be Simple, Accurate and Precise in
accordance with ICH Guidelines. This method can be applied for routine quality control analysis for the estimation of Ofloxacin and
Prednisolone Acetate in combined pharmaceutical dosage form.
KEY WORDS:Ofloxacin, Prednisolone Acetate, Stability Indicating RP-HPLC
ABSTRACT:
Tinidazole is nitro imidazole derivative, anti-parasitic drug used against protozoan infection. It is used as tissue amoebic ides for both
intestinal and extra intestinal amoebiasis. It has broad spectrum cidal activity against protozoa including Giardia Lamblia many anaerobic
bacteria such as fragilis, fusobacterium, clostridium perfrigens, cldifficile, helicobacter pylori. But as it is BCS Class-II drug, dissolution
from its dosage forms is too low and is rate limiting step in absorption of drug. Poor aqueous solubility and poor dissolution rate poses
difficulties in achieving predictable and reproducible in vivo/in vitro correlations and also bioavailability related problems. Further it also
undergoes extensive first pass effect leading to low and variable bioavailability. Thus improvement in extent and rate of dissolution is
highly desirable for such compounds, as this can lead to increased and more reproducible oral bioavailability and subsequently to
clinically relevant dose reduction and more reliable therapy. In this research attempt was made to improve solubility of tinidazole by solid
dispersion technique and prepared solid dispersions will be formulated in form of fast disintegrating tablets using various
superdisintegrants to improve solubility, bioavailability and patient compliance and clinical efficacy of tinidazole.
KEY WORDS: Solid Dispersion, DoE, Factorial design, Tinidazole, Fast disintegrating Tablets
ABSTRACT:
Chalcones was synthesized by one pot condensation of 1-chloro-(4-tolyloxy) benzene with 1-(4-hydroxylphenyl) ethanone followed by
condensation with various aromatic aldehydes. Synthesized chalcones (3a-3s) were refluxing with guanidine to yields various pyrimidine
derivatives. Synthesized pyrimidine on treatment with 4-acetamidobenzene sulfonyl chloride produced N-(4-(N-(4-(4-(4-(4-methoxy
phenoxy) phenoxy) phenyl)-6-phenylpyrimidin-2-yl (salfamoyl) phenyl) acetamide derivatives (B1-B19). All the prepared compounds were
characterized in by 1HNMR, 13CNMR, IR, MASS spectroscopic techniques. Biological evaluation of mention compounds was also made
in terms of gram positive bacteria such as Staphylococcus aureus, Bacillus megaterium and gram negative bacteria Escherichia coli,
Proteus vulgaris.
KEYWORDS: Acetamidobenzenesulfonyl chloride, Pyrimidine, Aldehydes, Chalcones, Antimicrobial activity, Guanidine.
ABSTRACT:
Aiming for the synthesis of new heterocyclic compound containing a testosterone moiety suitable for use as antibacterial agent. From
Ethisterone, a testosterone, Danazol was synthesised. Danazole is a first drug to especially treat endometriossis in the early 1970. There
were several publication available so far on Danazole for its synthesis, activity, derivatives of Danazole and its physical and chemical
properties inorder to further study. Synthesized Danazol then subjected to Glaser Hay coupling reaction to yield a Dimer compound. The
newly synthesized compound was tested for antibacterial activity.
KEY WORDS: Glaser Hay coupling, Danazol, endometriossis, tetramethyl-ethylenediamine, antibacterial activity.
ABSTRACT:
Background: The beginning of pharmaceutical in India was initiated at the Banaras Hindu University (BHU) in 1932 by Professor M. L.
Schroff. The pattern of educational in India is an industry and product oriented, unlike the situation of pharmacy in developed countries,
where pharmacy graduates involve themselves in pharmacy practice in patient related community pharmacy. Indian health care system is
not utilizing the service of Pharmacist yet it is the need of the hour. Objective: To evaluate the knowledge, practice and perception of
pharmacy practice amongst practicing registered pharmacists of Gujarat. Method: A self-administered questionnaire comprising of 23
questions covering aspects like pharmaceutical formulation, therapeutics, clinical pharmacy, jurisprudence and patient education was
prepared and validated. Registered pharmacist under Gujarat State Pharmacy Council from various cities of Gujarat were enrolled in the
study. After explaining the intention of survey, questionnaire was filled by the respondents in presentia. Result: Out of 120 participants,
111 respondents completed the process, which lead to response rate of 92.5%. Participants with qualification of Diploma in pharmacy
showed 77%, Bachelor and masters in pharmacy graduates showed 74% & 76% knowledge respectively and Ph.D professionals had
88% knowledge in the field of Pharmacy Practice. Doctor of Pharmacy (PharmD) qualified one participant had knowledge score of only
78%. It was also observed that the youngest age group and the oldest age group participants have given the highest amount of wrong
answers as compared to other age groups of participants. Conclusion: Knowledge, Practice and perception of current Indian pharmacy
practice need to be up gradated, regardless age and education background.
Key words:Ketoprofen, Thiocolchicoside, Acetonitrile, Method Development, Validation, Stability study, Methanol
ABSTRACT:
Staphylococcus aureus (S. aureus), a bacterium that causes skin infection as a result of skin colonization; it is becoming increasingly
resistant to many commonly used for antibiotics. TermeneliaBellerica or Baheda, traditionally used for the treatment of inflammation and
infection, in extract form has been shown to exhibited anti-bacterial activity against various bacteria. This study aims to examine the anti-
bacterial properties of T.bellerica towards S.aureus and formulate T.Bellerica into cream to determine its anti-bacterial properties.
Different concentrations (5%, 25%, 50%, 75% and 100%) of aqueous extract of and cream containing T.Bellerica were used in the disc
diffusion method for determination of antibacterial activity towards S.aureus. Microbiological pre- and post-testing were carried out for
both extract and cream formulations to determine their anti-bacterial properties. Both extract and cream containing T.Bellerica showed
good anti-bacterial properties against S.aureus. The anti-bacterial activities were proportional to the concentration of extract alone and in
the cream. All cream formulations showed satisfactory physical properties with smooth texture, emollient, non-greasy and easy to remove
with water. It is concluded that T.Bellerica has potential to be developed as a cream for skin infections caused by S.aureus. The zone of
inhibition is seen on the cup plate method of extract with conc. of 1000, 1500, 2000 µg/ml and the reading is compared with the standard.
The evaluation is done on the formulation.
KEY WORDS: Cellulitis, Termenillia bellerica, Cream formulation
