Formulation, Evaluation and Optimization of Carboxymethyl Tamarind Powder Based Baclofen Floating Matrix
Tablet Using 32 Full Factorial Designs
Bhatt Bhargav, Patel Anuradha and Narkhede Sachine
A Recent Approach On: Pulsatile Drug Delivery System
Abhirajsinh J. Solanki *, Jitendra J. Jaiswal, Suryabali K. Yadav
Special Issue
Special Thanks to Dr. Chirag Desai, BNB. Swaminarayan Pharmacy College,
Salvav, Gujarat, India for his outstanding efforts to make this issue in efect.
Volume 6, Issue 3, Special Issue Pages no. 221-364 , ISSN 2277-3681
Available online on 20 April 2016
J Pharm Sci Bioscientific Res. 2016; 6(3):221-364
A Review on Solid-Selfmicroemulsifying Drug Delivery System: Formulation Strategies to Improve the Bioavailability
of Poorly Soluble Drugs
Jitendra J. Jaiswal*, Abhirajsinh J. Solanki, Suryabali K. Yadav
Development and Validation of Analytical Method for Simultaneous Estimation of Mometasone Furoate and Fusidic
Acid in Pharmaceutical Dosage Form
Maulik N. Patel,Harsha D Jani, Priyanka S. Shah,Narmin A.Pirani
Simultaneous Estimation of TeneligliptinHydrobromide Hydrate and its Degradation Product by RP-HPLC Method
Shailesh V. Luhar*, Kamna R. Pandya, G K. Jani, Sachin B. Narkhed
Simultaneous Estimation of Sacubitril and Valsartan in Synthetic Mixture by RP-HPLC Method
Kena H. Patel , Shailesh V. Luhar, Sachin B. Narkhede
Simultaneous Estimation and Determination of Risperidone and Trihexyphenidyl by UV Spectrophotometric and
RP-HPLC Method
Janki R. Nayak, Shailesh V. Luhar, Sachin B. Narkhede
Copyright © 2014 JPSBR Publications
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RP-HPLC Method Development and Validation for Simultaneous Estimation of Nadifloxacin and Adapalene in
Bulk and Dosage Form
Khyati K. Patel, Atul Bendale, Shailesh V. Luhar,Sachin B. Narkhede
Development and Validation OF RP-HPLCMethod for the Simultaneous Estimation of Eplerenone and Torsemide in
Pharmaceutical Dosage Form
Krupali S. Patel, Atul Bendale, Shailesh V. Luhar, Sachin B. Narkhede
Development and Validation of Stability Indicating RP-HPLC Method for Montelukast Sodium and Desloratadine in
Pharmaceutical Dosage Form
Krupali K. Patel*, BhumikaSuthar, Shailesh V. Luhar, Sachin B. Narkhede
Analytical Method Development and Validation for Simultaneous Estimation of Cilnidipine, Olmesartan and
Chlorthalisone in Synthetic Mixture by RP-HPLC Method
Reenkal D. Patel*, Mr. Shailesh V. Luhar, Sachin B. Narkhede
Development and Validation of Analytical Method for Simultaneous Estimation of Theophylline and Montelukast in
Pharmaceutical Dosage Form
Parth H.Chauhan,Shailesh V.Luhar , Narmin A.Pirani
Development and Validation of Stability Indicating Analytical Method for Estimation of Cinnarizine and Dimenhydrinate
in Tablet Dosage Form
Suleman S. Khoja , Shailesh V.Luhar , Narmin A.Pirani
Formulation Evaluation and Optimization of Buccal Tablet of Ivabradine Hydrochloride
Patel Sweety, Mrs. Anuradha Patel and Dr. Sachine Narkhede
Stability Study of Gemigliptin and Simultaneous Estimation of Gemigliptin and its Degradation Product by RP-HPLC Method
Shailesh V. Luhar, Kajal R. Patel, G.K.Jani, Sachin B.Narkhede
Development and Validation of Stability Indicating RP-HPLC Method for Amlodipine Besylate and Perindopril Arginine
in Synthetic Formulation
Priya R. Rajput, Atul Bendale, Shailesh V. Luhar,Sachin B. Narkhede
A Review on Floating Pulsatile Tablets Novel Approach for Oral Drug Delivery Systems
Chirag U. Patil*, Ajay N. Talele, Amitkumar R. Chamadia
Synthesis and Antimicrobial Evaluation of Novel Azo Compounds Bearing Imidazolyl Moiety
D. K. Dodiya*, R. A. Shah, K. S. Nimavat
Synthesis and Antimicrobial Evaluation of Novel 1-Benzoyl Pyrazole Derivatives
D. K. Dodiya*, R. A. Shah,
ABSTRACT:
The present study was undertaken to assess the potential of Carboxymethylated Tamarind powder (CM-TP) as a matrix forming agent
in floating matrix tablet of Baclofen. Baclofen is a centrally acting muscle relaxant. Half life of baclofen is 3-4 hours and absorption
window is in upper gastrointestinal tract and intestine. This characteristic of drug shows that it is preferable to formulate a floating
dosage form. The drug and excipients were found to be compatible as confirmed by IR spectral studies. Floating matrix tablet of
Baclofen were prepared by wet granulation method using carboxymethyl tamarind as matrix former. A 32 full factorial design had been
applied in which two independent variables and two dependent variables were employed to optimize drug release profile and are
evaluated. Concentration of Carboxymethylated Tamarind (X1) and concentration of Sodium bicarbonate (X2) were taken as
independent variables. The dependent variables selected were % drug release (Y1) and Total floating time (Y2). The optimized
formulation showed a slow and complete drug release of 98.86±0.44 % over a period of 12 hr with 'R2' value 0.987 indicating that the
release mechanism was Non-fickian release. The R2 value is highest in Higuchi model so the drug release mechanism mainly follow
Higuchi model. The polymer carboxymethyl tamarind had significant effect on drug release which was seen in the study.
KEY WORDS: Carboxymethyl-tamarind, Baclofen, Floating matrix tablet, Sodium bicarbonate.
![[x]](JPSBR_Vol_6_Issue_1_htm_files/close.png "Close")
ABSTRACT:
Pharmaceutical invention are increasingly focusing on rapid drug delivery systems which enhanced desirable therapeutic objectives while
decreasing side effects. Recent trends indicate that drug delivery systems are especially suitable for achieving controlled or delayed release
oral formulations with low risk of dose dumping, flexibility of blending to achieved desirable release patterns with less inter- and intra-subject
variability. A pulsatile principles of drug delivery system seems to present the advantage that a drug can be released in the GI tract after a
definite time period of no drug release. Pulsatile drug delivery system (PDDS) concept was applied to increase the residence of the dosage
form having lag phase followed by a burst release. Diseases wherein PDDS are promising include Hypertension, asthma, peptic ulcer,
cardiovascular diseases, arthritis, and attention deficit syndrome in children. PDDS works on principle of time-controlling system like swelling
and Repturable membranes, soluble or erodible coating, capsule-shaped system, and multiparticulate system are primarily involved in the
control of release. PDDS showed excellent lag phase followed by burst release in distal part of small intestine which gives site- and time-
specific release of drugs acting as per chronotherapy of the diseases.
KEYWORDS:Pulsatile drug delivery system, Controlling plug, Eroding or soluble barrier, Multiparticulate, Repturable coating
ABSTRACT:
Poorly water soluble drug candidates are becoming more prevalent and it has been estimated that 40-50% of drug molecules
are poorly soluble in aqueous media or have a low permeability which does not allow for their adequate absorption from
gastrointestinal tract following by oral administration. Formulation scientists have to adopt different strategies to enhance their
absorption. Lipidic formulations are seen to be a promising approach to combat the challenges and especially self-
microemulsifying drug delivery(SMEDDS) system approach are used to increase the absorption of poorly absorbed drug
which ultimately increased there bioavailability. The attempts of various scientist to convert the liquid SMEDDS to solid-
SMEDDS by adsorption, spray drying, lyophilisation, melt granulation and extrusion techniques. Formulation of SMEDDS is a
potential strategy to deliver poorly soluble drug and low absorption drug with enhanced dissolution rate and bioavailability.
KEYWORDS: Self-microemulsifying, adsorption technique, surfactant, poorly water soluble drug, bioavailability, absorption,
ternary phase diagram
ABSTRACT:
Novel imidazolyl bearing azo compounds were synthesized by the reaction of Schiff base with diazonium salts
of different aromatic amines. All the newly synthesized azo compounds were characterized by different
spectroscopic techniques and elemental analyses. All the compounds were evaluated for their antimicrobial
activity.
KEYWORDS: Imidazolyl, Azo compounds, Schiff base, Antimicrobial activity
ABSTRACT:
Novel 1-benzoyl-5-(aryl)-{3-[4-(2-phenyl-4-benzylidene-5-oxo-imidazol-1-yl)]phenyl}-4,5-dihydropyrazols were
synthesized by the reaction of 4-benzylidene-1-{4-[3-(aryl)prop-2-enoyl]phenyl}-2-phenyl-imidazol-5-one with
hydrazine hydrate followed by reaction with benzoyl chloride in presence of pyridine. All the newly synthesized
pyrazoles were characterized by different spectroscopic techniques and elemental analyses. All the compounds
were evaluated for their antibacterial activity against S. aureus, E.coli and for their antifungal activity against C.
albicans.
KEYWORDS: Pyrazoles, Antibacterial activity, Antifungal activity
ABSTRACT:
A reversed-phase liquid chromatographic method has been developed and validated for estimation of Mometasone furoate and
Fusidic acid in cream form. RP-HPLC method, Column used was C18 (150 x 4.6 mm i.d.,5?m) with mobile phase containing 10
mM ammonium formate in water pH 5.5:Methanol (65:35 %v/v). The flow rate (1.0 ml/min) and wavelength (240 nm). The
retention time was found to be 4.325 mins and 8.109 mins of Fusidic acid and Mometasone furoate respectively. Correlation co-
efficient for Fusidic acid and Mometasone furoatewas found to be 0.999. Assay result of marketed formulation wasfound to be in
99.3 % and 98.3 % for Fusidic acid and Mometasone furoate respectively . The proposed method was validated with respect to
linearity, accuracy, precision androbustness. Recovery was found in the range of 99.5 %- 101.7 %. Statistical Analysis proves
that the developed methods weresuccessfully applied for the analysis of pharmaceutical formulations and can be used for routine
analysis of drugs in QualityControl laboratories.
KEYWORDS Mometasone furoate, Fusidic acid, HPLC, analytical method development, validation
ABSTRACT:
A simple, rapid, precise and accurate reversed-phase stability-indicating RP-HPLC method was developed and validated for the
simultaneous determination of Teneligliptin hydrobromide hydrate in marketed formulation (tablets). The method has shown
adequate separation for Teneligliptin hydrobromide from its associated main impurities and their degradation products. Separation
was achieved on a Shisedo C18column, 5μm, 250mm × 4.6 mm i.e. column using a mobile phase consisting of
Acetonitrile:Methanol: Water (30:40: 30 % v/v/v) at a flow rate of 1.0ml/min and UV detection at 246nm. The drugs are subjected to
acid hydrolysis, alkaline hydrolysis, oxidative degradation and thermal degradation to apply force degradation testing. The linearity
of the proposed method was investigated in the range of 50-300?g/ml (r2= 0.9996). The limit of detection was2.78 μg/ml and the
limit of quantification was 8.45 μg/ml.
KEY WORDS: Teneligliptin hydrobromide hydrate, RP-HPLC, Validation, Force Degradation.
ABSTRACT:
A simple, accurate, rapid and precise isocratic reversed-phase high-performance liquid chromatographic method has been
developed and validated for simultaneous determination of Sacubitril and Valsartan in synthetic mixture. The chromatographic
separation was carried out on C18 (250*4.6 mm, 5µm) column with a mixture of Acetonitrile: methanol: water, pH 3 adjusted with
ortho-phosphoric acid (30:50:20, %v/v) as mobile phase;at a flow rate of 1.0 ml/min. UV detection was performed at 267 nm. The
retention times were 2.464 and 3.264 min. for Sacubitril and Valsartan respectively. Calibration plots were linear over the
concentration range 50-250 μg/ml for Sacubitril and 50-250 g/ml Valsartan. The method was validated for system suitability,
accuracy, precision, linearity, and sensitivity. The proposed method was successfully used for quantitative analysis of tablets. No
interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is
specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the
method for routine determination of Sacubitril and Valsartan.
KEYWORDS: Sacubitril; Valsartan; RP-HPLC, reverse phase, validation,
ABSTRACT:
A simple, rapid, accurate, precise and rapid UV spectrophotometric and RP-HPLC methods were developed and validated for the
estimation of Risperidone and Trihexyphenidyl in tablet dosage form. In UV, Simultaneous equation and Absorbance Ratio
method were used.The wavelength ranges 280 nm for RIS and 258 nm for TRI in Simultaneous equation method and 268 nm
(iso-absorptive point) and 258 nm (?max of Trihexyphenidyl) were selected for Absorbance ratio method.RP - HPLC method was
developed using Sheisedo - C18 column (250* 4.6mm, 5?m as a Stationary Phase and Phosphate buffer (pH 3.5): Methanol
(70:30 v/v) as a mobile phase pumped at a flow rate of 1.0 ml/min. Quantification was achieved with ultraviolet detection at 268
nm over concentration ranges of 5-25 μg/ml for Risperidone and 5-25μg/ml for Trihexyphenidyl hydrochloride with mean accuracy
100.37% and 100.42% for Risperidone&Trihexyphenidyl hydrochloride respectively.
KEYWORDS: RP-HPLC method, Validation, Risperidone, Trihexyphenidyl hydrochloride
ABSTRACT:
A simple, accurate, rapid and precise isocratic high-performance liquid chromatographic (HPLC) method has been developed and validated
for simultaneous estimation of Nadifloxacin and Adapalene in pure powder and formulation. The HPLC separation was achieved on a
Sheisedo-C18 (250mm x 4.6mm, 5 ?m) using Acetonitrile: Methanol: Water (pH-2.8) (35:45:20 v/v) as mobile phase at flow rate of 1.0
ml/min. The calibration plot showed good linear relationship with r2=0.999 for NAD and r2=0.999 for ADA in concentration range of 100-500
?g/ml and 10-50 ?g/ml respectively. Limit of detection (LOD) and Limit of quantification (LOQ) were found to be 4.0984?g/ml and
12.4196?g/ml for Nadifloxacin and 1.1237?g/ml and 3.4053?g/ml for Adapalene. Assay of Nadifloxacin found to 99.37±0.4064% and
Adapalene found to 99.33±0.4041%. The method was validated as per ICH guideline. The method was successfully applied for routine
analysis of Nadifloxacin and Adapalene in pure powder and gel formulation.
KEYWORDS:Adapalene; Nadifloxacin; RP-HPLC method; Validation.
ABSTRACT:
A simple, precise, accurate, rapid RP-HPLC Method and UV Spectrophotometric Methods were developed and validated for
simultaneous estimation of Eplerenone and Torsemide in pharmaceutical dosage form.RP- HPLC was carried out by using Sheisedo C18
(250 * 4.6 mm, 5µm) column and Acetonitrile: Methanol: water (30:50:20 % v/v/v) as mobile phase, at 1.0 ml/min flow rate. Detection was
carried out at 268 nm. Retention time was found to be 2.53 min and 3.27min for Torsemide and Eplerenone, respectively.RP-HPLC
method was found to be linear over the range of 40-240µg/ml for Torsemide and 100-600µg/ml for Eplerenone.
KEY WORDS:Eplerenone, Torsemide, RP-HPLC Method,Validation
ABSTRACT:
A simple, rapid, precise and accurate stability-indicating RP-HPLC method was developed and validated for the simultaneous
determination of Montelukast Sodium and Desloratadinein pharmaceutical dosage form. Method was carried out by using Sheisedo C18
(250 * 4.6 mm, 5µm) column and Acetonitrile : Methanol : water (35:40:25 % v/v/v) as mobile phase at 1.0 ml/min flow rate. Detection
was carried out at 256 nm. Rt was found to be 2.224 min for Montelukast Sodium and 3.004min for Desloratadine. For stability study
drugs were subjected to acid hydrolysis, alkaline hydrolysis, oxidative degradation and thermal degradation. Montelukast Sodium was
highly susceptible to acidic and thermal condition. Pharmaceutical dosage form was more stable than Active pharmaceutical
ingredient.The linearity of the proposed method was investigated in the range of 100-600μg/ml (r2= 0.998) for Montelukast Sodium and
50-300 μg/ml(r2= 0.991) for Desloratadine. The limit of detection were 15.62μg/ml and 9.78 μg/ml and the limit of quantification were
46.88 μg/ml and 29.66μg/ml for Montelukast Sodium and Desloratadine respectively.
KEY WORDS:Montelukast Sodium, Desloratadine, Stability indicating RP-HPLC Method, Validation
ABSTRACT:
To developed and validate a simple and rapid isocratic reversed-phase high-performance liquid chromatography method (RP-HPLC) for
the simultaneous estimation of Cilnidipine, Olmesartan and Chlorthalidone in synthetic mixture. The chromatographic separation was
achieved by using mobile phase acetonitrile, methanol and water (40:20:20 %v/v/v) with 5ml of 0.5% ortho phosphoric acid (pH 3.8),
sheisedo C18 (4.6mm*250mm) 5µm. The mobile phase was pumped at a flow rate of 1.0ml/min and the eluents were monitored at
226nm. Retention times were 5.366 min, 2.693 min and 3.760 min for Cilnidipine, Olmesartan and Chlorthalidone respectively. Linearity
was observed in the concentration range of 50-300 µg/ml, 100-600 µg/ml and 60-360 µg/ml for Cilnidipine, Olmesartan and
Chlorthalidone respectively. The percentage recoveries found to be as for Cilnidipine 98.9-101.52%, Olmesartan 99.21-100.88% and
Chlorthalidone 99.03-100.81% respectively. All the parameters are validated as per ICH guidelines for the method validation and found to
be suitable for routine quantitative analysis in pharmaceutical dosage forms.
KEY WORDS: Validation, Development, Cilnidipine, Olmesartan, Chlorthalidone, RP-HPLC.
ABSTRACT:
A reversed-phase liquid chromatographic method has been developed and validated for estimation of Theophylline and Montelukast in
Tabletdosage form. RP-HPLC method, Column used was C18(150 x 4.6 mm i.d.,5μm) with mobile phase containing 0.3 % Triflouro acetic
acid in water pH 2.5: acetonitrile (20:80 %v/v). The flow rate (1.0 ml/min) and wavelength (230 nm). The retention time was found to be
4.201 mins and 6.124 mins of Theophylline and Montelukast respectively. Correlation co-efficient for Theophylline and Montelukast was
found to be 0.999. Assay result of marketed formulation wasfound to be in 99.8 % and 98.6 % for Theophylline and
Montelukastrespectively . The proposed method was validated with respect to linearity, accuracy, precision androbustness. Recovery was
found in the range of 99.5 %- 101.7 %. Statistical Analysis proves that the developed methods weresuccessfully applied for the analysis
of pharmaceutical formulations and can be used for routine analysis of drugs in QualityControl laboratories.
KEYWORDS Theophylline, Montelukast, HPLC, analytical method development, validation
ABSTRACT:
A reversed-phase liquid chromatographic method has been developed and validated for estimation of Cinnarizine and Dimenhydrinate in
Tabletdosage form. Chromatography was carried on PHENOMENEX C18 (250 x 4.6) mm; 5μm) analytical column using mobile phase
(0.2 % Formic Acid and 0.2 % tri ethyl amine (TEA ) in water pHadjusted to 5.0 with formic acid and methanol (40:60 % v/v) ) at a flow
rate of 01.0 ml/min. The detection was carried out at 260 nm. The retention time of Cinnarizine and Dimenhydrinateis found to be 2.954
min and 5.128 min respectively. Correlation co-efficient for cinnarizine and Dimenhydrinate was found to be 0.999. Assay result of
marketed formulation wasfound to be in 99.4 % and 98.8 % for Cinnarizine and Dimenhydrinate respectively . The proposed method was
validated with respect to linearity, accuracy, precision androbustness. Recovery was found in the range of 99.4 %- 101.5 %. Statistical
Analysis proves that the developed methods weresuccessfully applied for the analysis of pharmaceutical formulations and can be used
for routine analysis of drugs in QualityControl laboratories.
KEYWORDS Cinnarizine, Dimenhydrinate ,hplc ,analytical method development , validation
ABSTRACT:
To develop simple, accurate, precise, rapid and economical Stability Indicating RP-HPLC method for the Gemigliptin. In RP- HPLC,
estimation of Gemigliptin was carried out by using Shimadzu LC-2010, using Sheisdo C18 (250 * 4.6 mm, 5µm) column and with mobile
phase composition of Acetonitrile : Methanol : water (40:40:20 % v/v/v), at a flow rate of 1.0 ml/min was used. Detection was carried out
at 280 nm. Retention time of Gemigliptin was found to be 2.735 min. The force degradation of Gemigliptin was carried out by using acid
hydrolysis, alkaline hydrolysis, oxidative degradation and thermal degradation.The force degradation study for Gemigliptin indicates that
the drug significantly degrade under Alkaline and oxidative conditions. All the method was found to be simple, accurate, economical,
robust and reproducible. The proposed method was successfully applied for the simultaneous estimation of Gemigliptin and its
degradation product.RP-HPLC method was found to be linear over the range of 50-300 µg/ml for Gemigliptin. The method has been
validated for linearity, accuracy and precision, LOD, LOQ and system suitability according to ICH guideline.
KEY WORDS: Gemigliptin, RP-HPLC method, forced degradation, validation.
A simple, rapid, precise and accurate stability-indicating RP-HPLC method was developed and validated for the simultaneous
determination of Amlodipine Besylate(AMD) and Perindopril Arginine (PRD)pharmaceutical dosage form. Method was carried out by
using Sheisedo C18 (250 * 4.6 mm, 5µm) column and Acetonitrile : Methanol : water (30:40:30 % v/v/v) as mobile phase at 1.0 ml/min
flow rate. Detection was carried out at 227nm. Rt was found to be 3.90 min for AMD and 4.90 min for PRD. For stability study drugs were
subjected to acid hydrolysis, alkaline hydrolysis, oxidative degradation and thermal degradation. AMD was highly susceptible to acidic
and thermal condition. Pharmaceutical dosage form was more stable than active pharmaceutical ingredient. The linearity of the proposed
method was investigated in the range of 50-250 ?g/ml (r2= 0.997) for AMD and 50-250 ?g/ml(r2= 0.998) for PRD. The limit of detection
were0.115?g/ml and 0.146?g/ml and the limit of quantification were0.349?g/ml and 0.442?g/ml for AMD and PRD respectively.
KEY WORDS:Amlodipine Besylate, Perindopril Arginine, Stability indicating RP-HPLC Method, Validation
ABSTRACT:
Oral route of drug administration is one of the most convenient route and mostly preferred by majority of the population. The conventional
medications are been administered by oral route. There have been many recent advances in the oral drug delivery technologies and one
of the recent advances is the pulsatile drug delivery system. In this era of controlled and sustained drug delivery there are certain disease
conditions where these type of drug release is not required rather than this a pulsatile release of the drug when it is needed most is
required, and such type of release can be achieved through pulsatile drug delivery system. Moreover, further modifications can be
applied to the pulsatile drug delivery by its gastric retention and achieving drug release in pulse form in the stomach region.The trend of
floating pulsatile drug delivery system is also advantageous in site specific drug release in pulsed form.Oral pulsatile delivery is achieved
by means of a variety of release platforms, namely reservoir, capsular and osmotic devices. The aim of the present review is to outline
the rationale and main formulation strategies behind delayed-release dosage forms intended for the pharmacological treatment of
chronopathologies.
KEY WORDS: Pulsatile tablets, Dual pulse, Chronotherapeutics, Novel drug delivery.
