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Validated gradient stability indicating HPLC method for determining Diltiazem Hydrochloride and related substances in bulk drug and novel tablet formulation

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Journal of Pharmaceutical Analysis 2012年第3期2卷 226-237页

作者： Vivekanand A.Chatpalliwar Pawan K.Porwal Neeraj Upmanyu Department of Pharmaceutical Chemistry SSDJ College of PharmacyChandwadIndia Department of Pharmaceutical Science Pharmaceutical Chemistry DivisionUniversity of SagarSagarIndia

A stability-indicating liquid chromatographic method has been developed and validated for the determination of Diltiazem Hydrochloride(DTZ) together with its six related substances(Diltiazem sulphoxide,Imp-A,Imp-B,Imp-D,Imp-E,and Imp-F) in a laboratory mixture as well as in a novel tablet formulation developed *** chromatographic separation was achieved on a Hypersil BDS C18(150 mm*4.6 mm,5.0 μm) with mobile phase containing 0.2% Triethylamine(TEA) in gradient combination with acetonitrile(ACN) at a flow rate of 1.0 mL/min and the eluent was monitored at 240 *** the developed method,the resolution of DTZ from any pair of impurities was found to be greater than *** test solution and related substances were found to be stable in the diluent for 24 *** developed method resolved the drug from its known impurities,stated above,and also from additional impurities generated when the formulation was subjected to forced degradation;the mass balance was found close to 99.9%.Regression analyses indicate correlation coefficient value greater than 0.997 for DTZ and its six known *** LOD for DTZ and the known impurities was at a level below 0.02%.The method has shown good,consistent recoveries for DTZ(99.8-101.2%) and also for its six known impurities(97.2-101.3%).The method was found to be accurate,precise,linear,specific,sensitive,rugged,robust,and stability-indicating.

关键词： Diltiazem Hydrochloride Benzodiazepine Stability-indicating Related substances ich guidelines HPLC

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Enantiomeric Separation of S-Epichlorohydrin and R-Epichlorohydrin by Capillary Gas Chromatography with FID Detector

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American Journal of Analytical Chemistry 2016年第11期7卷 772-784页

作者： Cholleti Vijay Kumar Pavan Kumar Vasa Y. Ravindra Kumar Pasula Aparna Padi Pratyusha Dr. Reddy’s Laboratories Ltd. Active Pharmaceutical Ingredients IPDO Hyderabad India Department of Chemistry J.N.T. University Hyderabad India Department of Pediatrics SUNY Stony Brook Medical Center Stony Brook New York USA

The aim of this study was to develop a simple and derivatization free method for the Quantification of S-Epichlorohydrin in R-Epichlorohydrin by using a gas chromatography coupled with flame ionization detector (FID). Enantiopure epichlorohydrin was a valuable epoxide key starting material for preparing optically active Rivaroxaban. The enantiomeric separations of S-Epichlorohydrin and R-Epichlorohydrin were achieved on Gamaa-Dex-225 (30 meters × 0.25 mm I.D, 0.25 μm) column with a total run time of 30 min. Nitrogen was used as a carrier gas with constant pressure 25.0 psi. The critical experimental parameters such as, column selection, flow rate, injection volume and diluent were studied and optimized. Excellent correlation coeffient between peak responses and concentrations was >0.9998. The recoveries of S-Epichlorohydrin spiked in R-Epichlorohydrin were in the range from 98.2% to 102.8%. Limit of quantitation for S-Epichlorohydrin was sufficiently lower than limits specified by ich. The method has validated as per International Conference on Harmonization (ich) guidelines. A precise, accurate, linear and robust Gas Chromatography method was developed for the quantification of S-Epichlorohydrin in R-Epichlorohydrin for Rivaroxaban.

关键词： S-Epichlorohydrin R-Epichlorohydrin Method Development ich guidelines Method Validation Gas Chromatography

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