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Kaleemullah T.,Islamiah College | Ahmed M.,Islamiah College | Sharma H.K.,Aurobindo Pharma Ltd Research Center
Der Pharma Chemica | Year: 2011

The present paper describes the development of a reversed-phase high performance liquid chromatographic (RP-HPLC) method for N-Bromosuccinimide (NBS) determination in group of "sartans" pharmaceuticals. The gradient LC method employs solution A and solution B as mobile phase. The solution A contains 0.01%v/v Ortho-phosphoric buffer and Acetonitrile as Solution B. Successful chromatographic separation were achieved on a Zorbax XDB C18, 250mm x 4.6mm, 5μm particle size column without co-elution of drugs and its process related impurities and degradation products. The developed RP-HPLC method was validated with respect to specificity, linearity, accuracy, precision and sensitivity with detection limits and quantification limits are 0.007 mg/ml and 0.022 mg/ml respectively [1]. To the best of our knowledge, a rapid LC method for the determination of NBS in pharmaceuticals, disclosed in this investigation was not published elsewhere.


Narendra Kumar M.,Aurobindo Pharma Ltd Research Center | Pavan Kumar K.S.R.,Aurobindo Pharma Ltd Research Center | Jagadeesh Kumar V.,Aurobindo Pharma Ltd Research Center | John Prasanna S.,Aurobindo Pharma Ltd Research Center | And 2 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2011

A simple and sensitive ion chromatography method has been developed for the simultaneous assay of ibandronate sodium drug substance and the determination of its impurities. The separation was achieved on Allsep™ anion column 150mm×4.6mm, 7μm particle diameter. The mobile phase consisted of 1% (v/v) aqueous formic acid and acetone 98:2% (v/v); flow rate 1.0mlmin -1 at ambient temperature. The analytes were monitored by conductometric detector. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolytic, thermal and humidity degradation. Considerable degradation was achieved only under oxidative conditions. Mass balance was demonstrated in all stress conditions. The method was validated for specificity, precision, linearity, solution stability and accuracy. The limits of detection (LOD) and limits of quantification (LOQ) for impurities were in the range of 0.36-0.80μgml -1 and 1.00-2.40μgml -1, respectively. For ibandronate LOD was 38μgml -1 and LOQ was 113μgml -1. The average recoveries for impurities and ibandronate were in the range of 99.0-103.1% and the method can be successfully applied for the routine analysis of ibandronate sodium drug substance. © 2010 Elsevier B.V.


Khatavkar U.N.,Aurobindo Pharma Ltd Research Center | Khatavkar U.N.,Birla Institute of Technology | Shimpi S.L.,Aurobindo Pharma Ltd Research Center | Jayaram Kumar K.,Birla Institute of Technology | Deo K.D.,Aurobindo Pharma Ltd Research Center
Drug Development and Industrial Pharmacy | Year: 2013

The objective of this study is to develop, in vitro and in vivo evaluation of novel approaches for controlled release of paroxetine hydrochloride hemihydrate (PHH) in comparison to patented formulation PAXIL CR® tablets of GlaxoSmithKline (Geomatrix™ technology). In one of the approaches, hydrophilic core matrix tablets containing 85% of the dose were prepared and further coated with methacrylic acid copolymer to delay the release. An immediate release coating of 15% was given as top coat. The tablets were further optionally coated using ethyl cellulose. In the second approach, hydrophobic matrix core tablets containing metharylic acid copolymer were prepared. In the third approach, PHH was granulated with enteric polymer and further hydrophobic matrix core tablets were prepared. The effect of polymer concentration, level of enteric coating on drug release was evaluated by in vitro dissolution study by varying dissolution apparatus and the rotation speeds. It was found that increase in concentration of high viscosity hydroxypropylmethylcellulose (HPMC) resulted in reduction of the release rate. The drug release was observed to be dependent on the level of enteric coating and ethyl cellulose coating, being slower at increased coating. The release mechanism of PHH followed zero-order shifting to dissolution dependent by the increase of HPMC content. The formulation was stable without change in drug release rate. In vivo study in human volunteers confirmed the similarity between test and innovator formulations. In conclusion, HPMC-based matrix tablets, which were further coated using methacrylic acid copolymer, were found to be suitable for the formulation of single layer-controlled release PHH. © 2013 Informa Healthcare USA, Inc.


Rao P.S.,Aurobindo Pharma Ltd Research Center | Ray U.K.,Aurobindo Pharma Ltd Research Center | Hiriyanna S.G.,Aurobindo Pharma Ltd Research Center | Rao S.V.,Aurobindo Pharma Ltd Research Center | And 3 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2011

Impurities found in stressed and stability studies of Olanzapine (polymorphic form-I) [1-7] in both drug substance and drug product are described. These impurities are identified as 4-(4-methyl-1-piperazinyl)-3-hydroxymethylidene-1. H-benzo[b][1,4]diazepine-2(3H)-thione (hydroxymethylidene thione) and (Z)-4-(4-methyl-1-piperazinyl)-3-acetoxymethylidene-1. H-benzo[b][1,4]diazapine-2(3H)-thione (acetoxymethylidene thione). An oxidative degradation pathway of Olanzapine, for the formation of these impurities, has been proposed. © 2011 Elsevier B.V.


Rao P.S.,Aurobindo Pharma Ltd. Research Center | Ray U.K.,Aurobindo Pharma Ltd. Research Center | Gupta P.B.,Aurobindo Pharma Ltd. Research Center | Rao D.V.N.S.,Aurobindo Pharma Ltd. Research Center | And 3 more authors.
Journal of Pharmaceutical and Biomedical Analysis | Year: 2010

Rabeprazole sodium [1] is a proton pump inhibitor, used as an antiulcerative. During the manufacturing of rabeprazole sodium, we observed an unknown impurity at levels 0.05-0.1% in HPLC analysis along with the known potential impurities. This new unknown impurity was isolated using preparative liquid chromatography. Based on the complete spectral analysis (1H NMR, 13C NMR, DEPT, Mass and IR), this new impurity was designated as 2-[[(3-methyl-4-(methylthio)-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole (methylthio impurity of rabeprazole). Impurity isolation, structure elucidation and probable formation mechanism was discussed. © 2010 Elsevier B.V.


PubMed | Aurobindo Pharma Ltd Research Center
Type: Journal Article | Journal: Pharmaceutical development and technology | Year: 2013

The objective of this study is to develop and in vivo evaluation of novel monolithic matrix mini tablets approach to control the release of galantamine hydrobromide (GAH) in comparison with desired release profile to the Innovator formulation Razadyne() ER capsules. The direct compression method was employed for preparation of matrix mini tablets as against reservoir multiparticulate pellets of innovator formulation. The matrix swellings, dissolution similarity, mean dissolution time and dissolution efficiency of formulations were evaluated. It was found that increase in the concentration of high viscosity hydroxypropylcellulose (HPC) results reduction in release rate. The drug release was shown to be pH dependent with faster rate at lower pH. The release of GAH followed first order shifting to dissolution dependent by increase of HPC content. The formulation showed stability of drug release. In vivo prediction was done by Wagner-Nelson method. Prediction errors were estimated for Cmax and area under curve (AUC) and found to be not exceeding 15%. In vivo study in human volunteers confirmed the similarity between test and innovator formulations and pharmacokinetic values were comparable between actual and predicted. These results suggest that novel monolithic matrix approach could be suitable technique to formulate controlled release GAH.


PubMed | Aurobindo Pharma Ltd. Research Center
Type: Comparative Study | Journal: Journal of pharmaceutical and biomedical analysis | Year: 2010

Rabeprazole sodium [1] is a proton pump inhibitor, used as an antiulcerative. During the manufacturing of rabeprazole sodium, we observed an unknown impurity at levels 0.05-0.1% in HPLC analysis along with the known potential impurities. This new unknown impurity was isolated using preparative liquid chromatography. Based on the complete spectral analysis ((1)H NMR, (13)C NMR, DEPT, Mass and IR), this new impurity was designated as 2-[[(3-methyl-4-(methylthio)-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole (methylthio impurity of rabeprazole). Impurity isolation, structure elucidation and probable formation mechanism was discussed.


PubMed | Aurobindo Pharma Ltd Research Center
Type: Comparative Study | Journal: Drug development and industrial pharmacy | Year: 2013

The objective of this study is to develop, in vitro and in vivo evaluation of novel approaches for controlled release of paroxetine hydrochloride hemihydrate (PHH) in comparison to patented formulation PAXIL CR() tablets of GlaxoSmithKline (Geomatrix technology). In one of the approaches, hydrophilic core matrix tablets containing 85% of the dose were prepared and further coated with methacrylic acid copolymer to delay the release. An immediate release coating of 15% was given as top coat. The tablets were further optionally coated using ethyl cellulose. In the second approach, hydrophobic matrix core tablets containing metharylic acid copolymer were prepared. In the third approach, PHH was granulated with enteric polymer and further hydrophobic matrix core tablets were prepared. The effect of polymer concentration, level of enteric coating on drug release was evaluated by in vitro dissolution study by varying dissolution apparatus and the rotation speeds. It was found that increase in concentration of high viscosity hydroxypropylmethylcellulose (HPMC) resulted in reduction of the release rate. The drug release was observed to be dependent on the level of enteric coating and ethyl cellulose coating, being slower at increased coating. The release mechanism of PHH followed zero-order shifting to dissolution dependent by the increase of HPMC content. The formulation was stable without change in drug release rate. In vivo study in human volunteers confirmed the similarity between test and innovator formulations. In conclusion, HPMC-based matrix tablets, which were further coated using methacrylic acid copolymer, were found to be suitable for the formulation of single layer-controlled release PHH.


PubMed | Aurobindo Pharma Ltd Research Center
Type: Journal Article | Journal: Journal of pharmaceutical and biomedical analysis | Year: 2010

A simple and sensitive ion chromatography method has been developed for the simultaneous assay of ibandronate sodium drug substance and the determination of its impurities. The separation was achieved on Allsep anion column 150 mm 4.6 mm, 7 m particle diameter. The mobile phase consisted of 1% (v/v) aqueous formic acid and acetone 98:2% (v/v); flow rate 1.0 ml min(-1) at ambient temperature. The analytes were monitored by conductometric detector. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolytic, thermal and humidity degradation. Considerable degradation was achieved only under oxidative conditions. Mass balance was demonstrated in all stress conditions. The method was validated for specificity, precision, linearity, solution stability and accuracy. The limits of detection (LOD) and limits of quantification (LOQ) for impurities were in the range of 0.36-0.80 g ml(-1) and 1.00-2.40 g ml(-1), respectively. For ibandronate LOD was 38 g ml(-1) and LOQ was 113 g ml(-1). The average recoveries for impurities and ibandronate were in the range of 99.0-103.1% and the method can be successfully applied for the routine analysis of ibandronate sodium drug substance.


PubMed | Aurobindo Pharma Ltd Research Center
Type: Journal Article | Journal: Scientia pharmaceutica | Year: 2012

A simple and sensitive ion chromatography method has been developed for the determination of cyclopropylamine (CPA) in nevirapine (NEV) and moxifloxacin HCl (MOX) pharmaceutical drug substances. Efficient chromatographic separation was achieved on a Metrosep C4, 5 m (250 mm 4.0 mm) column. The mobile phase consists of 5 mM hydrochloric acid containing 10% (v/v) acetonitrile and was delivered in an isocratic mode at a flow rate of 0.9 mL min(-1) at 27C. A conductometric detector was used for the detection of the analyte. The drug substances were subjected to stress conditions including oxidation, thermal, photolytic and humidity for the evaluation of the stability-indicating nature of the method. The method was validated for specificity, precision, linearity, accuracy and solution stability. The limit of detection (LOD) and limit of quantification (LOQ) values are 0.10 g mL(-1) and 0.37 g mL(-1) respectively. The linearity range of the method is between 0.37 g mL(-1) and 1.5 g mL(-1) and the correlation coefficient is found to be 0.9971. The average recoveries of CPA in NEV and MOX are 97.0% and 98.0%, respectively.

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