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Isolation and Characterization of R-Enantiomer in Ezetimibe

American Journal of Analytical Chemistry 2013年第9期4卷 488-495页

作者： Kameswararao Chimalakonda Venugopal Kamani Madhusudhan Gutta srinivasulu Polisetty sai venkata srinivas koduri Inogent laboratories Pvt Ltd. IDA-Nacharam Jawaharlal Nehru Technological University Hyderabad Hyderabad India

A simple and rapid Supercritical Fluid Chromatography (SFC) method has been developed to isolate and characterize R-Isomer of Ezetimi be by using normal phase Chiral Cel OD-H with 250 mm × 30 mm, 5 microns column using a mobile phase system containing super critical fluid carbondi oxide (Co2) and the percentage of 2-Propanol as a mobile phase (85:15) and detection at 230 nm. The isolated R-Isomer is characterized by using UV-vis, FT-IR, ESI-MS, HPLC1H and 13C NMR. The purity of isolated R-Isomer is about 98%.

关键词： Isolation Characterization (R)-Isomer Ezetimibe Supercritical Fluid Hromatography (SFC)

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Development and Validation of Chiral HPLC Method for Identification and Quantification of (R)-Enantiomer in Ezetimibe

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American Journal of Analytical Chemistry 2012年第7期3卷 478-483页

作者： Kameswara Rao Chimalakonda venkatanarayana Gudala Madhusudhan Gutta srinivasulu Polisetty sai venkata srinivas koduri Jawaharlal Nehru Technological University Inogent Laboratory Hyderabad India

A normal phase enantioselective high performance liquid chromatographic method was developed for enantiomeric resolution of Ezetimibe it reduces the overall delivery of cholesterol to the liver. The enantiomers of Ezetimibe were resolved on a Chiral Pak AS-H (250 × 4.6 mm, 5 μm) column using a mobile phase system containing n-Hexane, etha-nol, 2-Propanol and Trifloroacetic acid (84:12:4:0.1 v/v). The resolution between enantiomers was found to be more than 2.0. The limit of detection and limit of quantification of (R)-enantiomer were found to be 0.2 μg/mL and 0.5 μg/mL, respectively, for 10 μL injection volume. The sample solution and mobile phase were found to be stable for at least 48 h. The final optimized method was successfully applied to separate (R)-enantiomer from Ezetimibe and was proven to be reproducible and accurate for the quantitative determination of (R)-enantiomer in bulk drugs.

关键词： Ezetimibe (R)-Enantiomer Identification Quantification and Validation

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Development and Validation of Stability Indicating LC Method for Olmesartan Medoxomil

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American Journal of Analytical Chemistry 2012年第2期3卷 153-160页

作者： Chimalakonda Kameswara Rao Kakumani Kishore Kumar Maddala VijayaLaxmi Polisetty srinivasulu Gutta Madhusudhan Khagga Mukkanti koduri sai venkata srinivas Analytical Development Laboratory Inogent laboratories Private Limited Hyderabad India Centre for Chemical Sciences Institute of Science and Technology Jawaharlal Nehru Technological University Hyderabad India

The present method provides the detailed description of development and validation of a simple stability indicating re- verse phase column liquid chromatographic method for Olmesartan in the presence of its impurities namely Imp-A, Imp-B, Imp-C, Imp-D, Imp-E, Imp-F and Imp-G and degradation products generated from forced degradation studies. The drug substance was subjected to stress conditions of aqueous hydrolysis, Oxidative, photolytic and thermal stress degradation. The degradation of Olmesartan was observed under acid hydrolysis, base hydrolysis and peroxide. The drug was found to be stable to other stress conditions attempted. Successful separation of the drug from synthetic impu- rities and degradation products formed under stress conditions was achieved on symmetry C18, 150 mm × 4.6 mm, 5μ column using a phosphate buffer, Acetonitrile and Milli Q water. The developed LC method was validated with respect to specificity, linearity, accuracy, precision, raggedness and robustness. The assay method was found to be linear in the range of 250 μg?mL–1 to with 1000 μg?mL–1 correlation coefficient of 0.9999 and the linearity of the impurities was es- tablished from LOQ to 0.4%. Recoveries of assay and impurities were found between 98.5% and 101.2%. The devel- oped LC method to determine the related substances and assay determinations of Olmesartan can be used to evaluate the quality of regular production samples and stability samples. To best of our knowledge, the validated stability indi- cating LC method which separates all the impurities disclosed in this investigation was not published elsewhere.

关键词： Olmesartan Validation Degradation Products and Related Substances

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