A1 Refereed original research article in a scientific journal
Stability-Indicating Assay Method for Estimation of Olmesartan Medoxomil and its Metabolite
Authors: Trivedi P, Kartikeyan C, Kachave R, Bhadane R
Publisher: TAYLOR & FRANCIS INC
Publication year: 2009
Journal: Journal of Liquid Chromatography and Related Technologies
Journal name in source: JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
Journal acronym: J LIQ CHROMATOGR R T
Article number: PII 910537573
Volume: 32
First page : 1516
Last page: 1526
Number of pages: 11
ISSN: 1082-6076
DOI: https://doi.org/10.1080/10826070902901606
Abstract
A novel stability indicating high performance liquid chromatographic assay method was developed and validated for Olmesartan medoxomil and its degradant product. An isocratic HPLC method was developed to separate the drug from the degradation products, using an Inertsil-ODS-3 (C-18) Column (5m, 250mm4.60mm). A mixture of phosphate buffer (pH 4.0) and methanol (30:70) was used as mobile phase. The flow rate was 1.0mL/min and the detection was carried out at 230nm. The validation studies were carried out fulfilling the International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intra and inter day precision), accurate, and robust.
A novel stability indicating high performance liquid chromatographic assay method was developed and validated for Olmesartan medoxomil and its degradant product. An isocratic HPLC method was developed to separate the drug from the degradation products, using an Inertsil-ODS-3 (C-18) Column (5m, 250mm4.60mm). A mixture of phosphate buffer (pH 4.0) and methanol (30:70) was used as mobile phase. The flow rate was 1.0mL/min and the detection was carried out at 230nm. The validation studies were carried out fulfilling the International Conference on Harmonisation (ICH) requirements. The procedure was found to be specific, linear, precise (including intra and inter day precision), accurate, and robust.
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