Development and Validation of Stability Indicating high performance liquid chromatographic Method for Olmesartan medoxomil and Indapamide in Tablet Dosage form
Journal Title: Indian Journal of Research in Pharmacy and Biotechnology - Year 2015, Vol 3, Issue 2
Abstract
An approach of forced degradation study was successfully applied for the development of a stability-indicating high performance liquid chromatographic method for simultaneous determination of Olmesartan medoxomil and Indapamide in a formulation in the presence of its degradation products. In the present study a simple, accurate & precise reverse phase liquid chromatographic method has been developed & validated for simultaneous estimation of Olmesartan medoxomil & Indapamide in tablet dosage form. Developed Method was achieved on symmetry C18 (150 mm × 4.6 mm, 5 μ) column using a Acetonitrile: 0.02 M Na2HPO4 (45:55 v/v) mobile phase and pH 7 adjusted with ortho phosphoric acid. Isocratic elution mode at a flow rate of 1.0 ml/min at Room temperature with a load of 20μl Injection volume. The detection was carried out at 240 nm. The linearity of the proposed method was investigated in the range of 50-250 microg/mL (r2 = 0.998) for Olmesartan medoxomil and 10-50 microg/mL (r2 = 0.998) for Indapamide. The retention time of Olmesartan medoxomil & Indapamide were found to be around 4.79 min & 7.59 min respectively. The drug substances were subjected to stress conditions of acid hydrolysis, base hydrolysis, Oxidative, photolytic and thermal. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision, robustness, LOD and LOQ.
Authors and Affiliations
Rucha A Patel,Meghna P Patel, Hasumati A Raj, Nehal Shah
Keywords
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- EP ID EP33297
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