Papers by Arunadevi Birajdar
Research Journal of Pharmacy and Technology, Dec 28, 2008
sample solutions were injected to chromatographic system using Rheodyne Injector. The UV detector... more sample solutions were injected to chromatographic system using Rheodyne Injector. The UV detector used in this HPLC system was Czerny turners mount monochromater with deuterium lamp as light source. The chromatographic and the integrated data were recorded using Hercule 2000 (interface) computer system. Data processing was carried out using Borwin® Version 1.5software. Abstract: A reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of atorvastatin and ramipril in marketed formulation is developed. The determination was carried out on a HIQ SII C18 column -10 (4.5 mm x 250 mm).column using a mobile phase of acetonitrile: 0.02 M Potassium dihydrogen phosphate (pH 3.2) (75: 25%v/v). The flow rate was 1 ml/min with detection at 217 nm. The Valsartan is used as internal standard in this method. The retention time for atorvastatin was 6.1 min, for ramipril 3.43 min. Atorvastatin and ramipril showed a linear response in the concentration range of 20-180 μg/ml and 10-90 μg/ml respectively. The correlation co-efficient ('r' value) for atorvastatin and ramipril was 0.9999 for both drugs. The results of analysis have been validated statistically and by recovery studies. The percentage recoveries obtained for atorvastatin and ramipril ranges from 99.04 to 101.15 %.
Indian Journal of Pharmaceutical Sciences, 2008
Meyyanathan, et al.: Simultaneous RP-HPLC Estimation of Nebivolol and Hydrochlorothizide A simple... more Meyyanathan, et al.: Simultaneous RP-HPLC Estimation of Nebivolol and Hydrochlorothizide A simple, selective, rapid, precise and economical reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of nebivolol and hydrochlorthiazide from pharmaceutical formulation. Phenomenex Gemini C 18 (25 cm×4.6 mm i.d., 5 µ) column with a mobile phase consisting of acetonitrile: 50mM ammonium acetate (adjusted to pH 3.5 using orthophosphoric acid) (70:30 v/v) at a fl ow rate of 1.0 ml/min was used. Detection was carried out at 254 nm. Probenecid was used as an internal standard. The retention times of probenecid, nebivolol and hydrochlorthiazide were 13.05, 3.32 and 4.25 min, respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation and solution stability. The proposed method can be used for the estimation of these drugs in combined dosage forms.
Indian Journal of Pharmaceutical Education and Research, 2010
Two simple, precise and reproducible UV spectrophotometric methods, simultaneous equation method ... more Two simple, precise and reproducible UV spectrophotometric methods, simultaneous equation method and Q-value analysis method, have been developed and validated for the simultaneous estimation of nebivolol hydrochloride and valsartan used as cardiovascular drugs available in capsule dosage form and nebivolol hydrochloride with hydrochlorothiazide used as antihistaminic H blocker available in tablet dosage form. The methods are based on the 1
Journal of emerging technologies and innovative research, Nov 1, 2020
Reverse phase high performance liquid chromatographic was developed for the estimation of Clobeta... more Reverse phase high performance liquid chromatographic was developed for the estimation of Clobetasol Propionate in bulk & Formulation and to validate the developed methods according to ICH Q2 (R1) guidelines. Analytical method development was started with preliminary studies of the Clobetasol Propionate according to USP 2010. Being freely soluble in Acetonitrile, stock solutions of the drugs were prepared in acetonitrile (100%). The RP-HPLC method for estimation of Clobetasol Propionate dosage form was developed. The quantification was carried out by using Phenomenex Luna C18 column (150 mm × 4.6 mm, 5 m) as stationary phase and Acetonitrile: Water (51:49) as mobile phase. Mobile phase was maintained at a flow rate of 0.8 ml/min. The UV detector was operated at 242 nm at 30 o C and Clobetasol propionate eluted at RT 15.7 min.
Acta Scientific Pharmaceutical Sciences
Indian drugs, Nov 25, 2022
Asian Journal of Pharmaceutics, 2008
A reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous esti... more A reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of amlodipine and metoprolol in marketed formulation is developed. The determination was carried out on a Kromasil C18 (250 x 4.6 mm, 5 µm) column using a mobile phase of 0.02 M phosphate buffer solution: acetonitrile (70:30v/v, pH 3.0). The flow rate was 1.0ml/min with detection at 221 nm. The retention time for amlodipine was 2.57 min and for metoprolol 4.49 min. Amlodipine and metoprolol showed a linear response in the concentration range of 10-110 µg/ml. The correlation coefficient ('r' value) for amlodipine and metoprolol was 0.9991 and 0.9992, respectively. The results of analysis have been validated statistically and by recovery studies. The percentage recoveries obtained for amlodipine and metoprolol ranges from 100.04 to 100.57%.
A simple high-performance liquid chromatography RP-HPLC and two reproducible ultraviolet spectrop... more A simple high-performance liquid chromatography RP-HPLC and two reproducible ultraviolet spectrophotometric methods were developed and validated for the estimation of nebivolol HCl and valsartan simultaneously in combined pharmaceutical solid dosage form. The wavelength fixed for spectrophotometric measurement of valsartan at 246.6 nm, nebivolol HCl at 280.2 nm for the simultaneous equation and for the Q-analysis measurement the two wavelengths fixed are 246.6 nm and 275.0 nm. The linearity obtained for nebivolol HCl in the range of 0.5-2.5 µg/ml and 5-25 µg/ml for valsartan by spectrophotometric method. The nebivolol HCl and valsartan were analyzed by HPLC using reverse phase C18 column (25 cm x 4.6 mm i.d., 5 µm particle size), by isocratic mobile phase consisted of 50mM ammonium acetate buffer adjusted to pH 3.5 and acetonitrile (30:70 v/v), at a flow rate
Journal of Developing Drugs, Nov 20, 2015
Q based DOE approach was explored to study the effect of various factors influencing the optimisa... more Q based DOE approach was explored to study the effect of various factors influencing the optimisation of HPLC method for the simultaneous estimation of the four drugs viz. Ofloxacin (OFX), Ornidazole (ORN), Terbinafine Hydrochloride (TBH) and Clobetasol Propionate (CBP) in bulk drug and cream formulation. A full factorial design was employed to study the factors such as pH of the mobile phase, initial percentage of organic content for gradient elution (%BI) and gradient time (tG). The optimal conditions obtained after applying the principles of QbD with good system suitability parameters for all four drugs were found to be at pH 2.6, %BI as 24% of acetonitrile and gradient time of 4 min. The optimal conditions were found to be in a good agreement with the experimental results. The HPLC method thus developed was validated using ICH guidelines and was applied for the assay of cream formulation. The percentage recoveries were found to be 99.74±0.39 for OFX, 98.72±0.71 for ORN, 98.19±0.23 for TBH and 99.05±0.76 for CBP. The HPLC method was successfully applied to study the in vitro permeability of cream formulation in rat skin using Franz diffusion cell.
Solid dispersion is used for enhancing dissolution rate of a therapeutically active substance and... more Solid dispersion is used for enhancing dissolution rate of a therapeutically active substance and in turns its absorption and in vivo efficacy. Solid dispersion is generally prepared with drug which is having poor aqueous solubility and hydrophilic carrier. Generally polyethylene glycol, polyvinyl pyrrolidone, mannitol, urea, gums, eudragit are used as hydrophilic carriers. Certain hydrophilic swellable polymers sodium carboxy methyl cellulose, pregelatinized starch, sodium starch glycolate are also used. Sometimes surfactant is also added to further improve wetting property of solid dispersion. In solid dispersion particle size of drug is reduced or a crystalline pure drug is converted into amorphous form and hence the solubility of drug is increased. Solid dispersion is not only used in improving dissolution rate of poorly water soluble drug but also in masking the taste of the drug substance, preparing rapid disintegration oral tablets and in producing sustained release microsphe...
Researchers throughout the world are focusing intensively on the methods for the development of n... more Researchers throughout the world are focusing intensively on the methods for the development of new drug delivery systems to enhance patient’s compliance. The oral route is the most convenient route for administration of solid dosage form, about 85% of solid dosage administered by oral route because of advantages over others. The oral route however still remained as the best administration route of therapeutic agents for its ease of ingestion, pain avoidance and versatility. Hence, fast dissolving tablets become an emerging trend in the pharmaceutical industry. Fast dissolving tablets are ideal for all types of people, including for people who have swallowing difficulties, paediatric, geriatric, and bedridden patients. The objective of the present article is to highlight traveller friendly orodispersible tablet by direct compression using superdisintegrant materials, the various kinds of superdisintegrants along with their role in tablet disintegration and drug release, which are be...
Atorvastatin calcium (AST) is an anticholestermic agent characterize by low solubility and high p... more Atorvastatin calcium (AST) is an anticholestermic agent characterize by low solubility and high permeability which corresponds to BCS class II drug. The purpose of this study was to improve the solubility and dissolution rate of poorly water soluble drug AST by solid dispersion technique using super diintegrants such as Sodium starch glycolate (SSG) and Crospovidone (CPD). Method: The solid dispersion of AST by physical mixing and solvent evaporation method were prepared using 1:1,1:3,1:5 and 1:7 ratio of drug to super disintegrants. Result: Solid dispersion were evaluated for Drug Content, Saturation solubility studies, Dissolution rate studies, Fourier Transform Infrared spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC). The results of FTIR demonstrate no detectable interaction between drug and super disintegrant and DSC analysis showed that sharp melting point was completely disappeared suggesting that the AST molecularly dispersed in amorphous in form. Conclusion: ...
technicaljournalsonline.com
An accurate and reproducible UV-spectrophotometric methods and liquid chromatographic assay metho... more An accurate and reproducible UV-spectrophotometric methods and liquid chromatographic assay method were developed and validated for the determination of mosapride and pantaprazole in capsule formulation. Two wavelengths were selected for each UV method, first simultaneous equation 274 nm, 288.2 nm and second Q value analysis method 274 nm, 302 nm was the isobestic point for both the drugs. The 30 mM ammonium sulphate buffer : acetonitrile (50:50, v/v) was used for reverse-phase liquid chromatography to determine the contents of mosapride and pantaprazole in combination-capsule dosage form. The UV and HPLC methods were validated by determining parameters such as specificity, linearity, LOD and LOQ, precision, accuracy, ruggedness and robustness. The methods were found to be specific against placebo interference. Linearity was evaluated over the concentration range of 5-50.0 µg/mL by UV and 0.5 to 5.0 µg/mL by HPLC method respectively, for mosapride and pantaprazole (the value of R 2 0.999 found were by both the methods for mosapride and pantaprazole). Both the intraday and interday precision values of the systems and methods were determined. The accuracy of the methods ranged from 99.99 to 102.24 % for mosapride and from 100.45 to 101.22 % for pantaprazole. The proposed methods were found to be robust when slight but deliberate changes were made in analytical conditions. The developed methods were found suitable for the simultenous estimation of mosapride and pantaprazole in capsule formulation as well in raw materials for quality control.
Indian Journal of Pharmaceutical Sciences, 2009
Nebivolol hydrochloride (NEB, fig. ), 1-(6-fluorochroman-2-yl)-{[2-(6-fluorochroman-2yl)-2-hydrox... more Nebivolol hydrochloride (NEB, fig. ), 1-(6-fluorochroman-2-yl)-{[2-(6-fluorochroman-2yl)-2-hydroxyethyl]amino}ethanol, is a selective β 1 blocker . Literature assessment showed that high performance liquid chromatography (HPLC), high performance thin layer chromatography (HPTLC) , and liquid chromatography-mass spectroscopy (LC-MS) methods are reported for estimation of NEB in dosage formulations and in biological fluids. Valsartan (VAL, fig. ), 3-methyl-2-[pentanoyl-[[4-[2-(2H-tetrazol-5-yl)phenyl]phenyl] methyl]amino]butanoic acid, is an angiotensin II receptor antagonist . Both these drugs are used for the treatment of high blood pressure and other cardiovascular pathophysiologic conditions. A LC-MS and HPLC method are reported for estimation of VAL in human plasma. The present research work describes rapid, accurate, sensitive and reproducible RP-HPLC method for simultaneous estimation of NEB and VAL from the capsule formulation. The HPLC system used was a computer based Jasco series instrument comprising of a pump PU-2080 and a UV detector UV-2070. Manual injections were carried out using a Rheodine injector with a fixed 20 µl external loop. The chromatographic separations were performed on a HIQ sil C 18 ODS column (250×4.6 mm i.d., 5 µm particle size), operating at ambient temperature, using a mobile phase consisting of methanol:water (80:20 v/v) with addition of 0.1 percent 1-hexanesulfonic acid monohydrate sodium salt as an ion-pairing reagent. The mobile phase was filtered through 45µm nylon membrane filter. A Shimadzu AY 120 analytical balance was used for weighing. A PCi ultrasonicator was used for sonication. Mobile phase was used for preparation of drug samples throughout the analysis. HPLC grade methanol and 1-hexanesulfonic acid monohydrate sodium salt were purchased from Loba Chem. Pure drug samples of NEB and VAL was kindly supplied as gift samples by Emcure Pharm.
An accurate and reproducible liquid chromatographic assay method was developed and validated for ... more An accurate and reproducible liquid chromatographic assay method was developed and validated for the determination of Atorvastatin and Fenofibrate in capsule formulation. Water (pH 4.0) and acetonitrile (20:80, v/v) was used for reversephase liquid chromatography at detection wavelength 254 nm to determine the contents of Atorvastatin and Fenofibrate in combination capsule dosage form. The method was validated by determining parameters such as specificity, linearity, LOD and LOQ, precision, accuracy, ruggedness and robustness. The method was found to be specific against placebo interference. Linearity was evaluated over the concentration range of 1.0 to 6.0 μg/mL and 5.0-50.0 μg/mL for both Atorvastatin and Fenofibrate (the correlation of coefficient obtained was 0.999 for both). The intraday and interday precision values of the system and method were determined. The accuracy of the method ranged from 99.99 to 102.24% for Atorvastatin from 100.45 to 101.22% for Fenofibrate. The prop...
Research Journal of Pharmacy and Technology, 2008
sample solutions were injected to chromatographic system using Rheodyne Injector. The UV detector... more sample solutions were injected to chromatographic system using Rheodyne Injector. The UV detector used in this HPLC system was Czerny turners mount monochromater with deuterium lamp as light source. The chromatographic and the integrated data were recorded using Hercule 2000 (interface) computer system. Data processing was carried out using Borwin® Version 1.5software. Abstract: A reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of atorvastatin and ramipril in marketed formulation is developed. The determination was carried out on a HIQ SII C18 column -10 (4.5 mm x 250 mm).column using a mobile phase of acetonitrile: 0.02 M Potassium dihydrogen phosphate (pH 3.2) (75: 25%v/v). The flow rate was 1 ml/min with detection at 217 nm. The Valsartan is used as internal standard in this method. The retention time for atorvastatin was 6.1 min, for ramipril 3.43 min. Atorvastatin and ramipril showed a linear response in the concentration range of 20-180 μg/ml and 10-90 μg/ml respectively. The correlation co-efficient ('r' value) for atorvastatin and ramipril was 0.9999 for both drugs. The results of analysis have been validated statistically and by recovery studies. The percentage recoveries obtained for atorvastatin and ramipril ranges from 99.04 to 101.15 %.
A simple high-performance liquid chromatography RP-HPLC and two reproducible ultraviolet spectrop... more A simple high-performance liquid chromatography RP-HPLC and two reproducible ultraviolet spectrophotometric methods were developed and validated for the estimation of nebivolol HCl and valsartan simultaneously in combined pharmaceutical solid dosage form. The wavelength fixed for spectrophotometric measurement of valsartan at 246.6 nm, nebivolol HCl at 280.2 nm for the simultaneous equation and for the Q-analysis measurement the two wavelengths fixed are 246.6 nm and 275.0 nm. The linearity obtained for nebivolol HCl in the range of 0.5-2.5 μg/ml and 5-25 μg/ml for valsartan by spectrophotometric method. The nebivolol HCl and valsartan were analyzed by HPLC using reverse phase C18 column (25 cm x 4.6 mm i.d., 5 μm particle size), by isocratic mobile phase consisted of 50mM ammonium acetate buffer adjusted to pH 3.5 and acetonitrile (30:70 v/v), at a flow rate of 0.8 ml/min in the detection wavelength of 275 nm. The loratidine was used as an internal standard. The linearity and range...
Two simple, accurate and sensitive analytical methods have been developed for the simultaneous de... more Two simple, accurate and sensitive analytical methods have been developed for the simultaneous determination of Rabeprazole and Domperidone in pharmaceutical solid dosage form. The first method involves UV-spectrophotometric determination of both drugs in combination, using Qanalysis method. It involves absorbance measurement at 291.6 nm (λmax of Rabeprazole) and 240 nm isobestic point in solvent (0.1N NaoH), Sodium hydroxide. The method obeys Beer’s law over linearity range for Rabeprazole 2 – 12 μg mL-1 and for Domperidone 3-18 μg mL-1 respectively. The second method involves HPLC separation of Rabeprazole and Domperidone drugs in reverse phase mode using Phenomenx C18 column. Linearity was obtained in the concentration range of 0.5-5.0 μg mL-1 for Rabeprazole and 0.75-7.5 μg mL-1 Domperidone. The detection wavelength was 220 nm. Pantaprazole was used as internal standard in10 μg mL–1 concentration. Relative standard deviation (R.S.D) for both methods was found <2.0%.The propos...
Reverse phase high performance liquid chromatographic was developed for the estimation of Clobeta... more Reverse phase high performance liquid chromatographic was developed for the estimation of Clobetasol Propionate in bulk & Formulation and to validate the developed methods according to ICH Q2 (R1) guidelines. Analytical method development was started with preliminary studies of the Clobetasol Propionate according to USP 2010. Being freely soluble in Acetonitrile, stock solutions of the drugs were prepared in acetonitrile (100%). The RP-HPLC method for estimation of Clobetasol Propionate dosage form was developed. The quantification was carried out by using Phenomenex Luna C18 column (150 mm × 4.6 mm, 5 m) as stationary phase and Acetonitrile: Water (51:49) as mobile phase. Mobile phase was maintained at a flow rate of 0.8 ml/min. The UV detector was operated at 242 nm at 30C and Clobetasol propionate eluted at RT 15.7 min. Keywords-Clobetasol propionate,hplc,validation Introduction Clobetasol propionate Clobetasol propionate is used to treat moderate to severe plaque psoriasis . as...
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Papers by Arunadevi Birajdar