DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR DETERMINATION OF HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL AND THEIR RELATED SUBSTANCES IN COMBINED TABLET DOSAGE FORM

作者: Avani B. Chokshi , Pritesh R. Desai , Urvesh Mahendrabhai Patel

DOI:

关键词: Dosage formChromatographic separationHydrochlorothiazidePhosphate buffered salineHYDROCHLOROTHIAZIDE/OLMESARTANChromatographyChemistryOlmesartan

摘要: Objective: Development of RP-HPLC method for determination Hydrochlorothiazide (HCTZ), Olmesartan medoxomil (OLM) and their related substances in combined tablet dosage form validation the developed method. Methods: Gradient mobile phase system was used estimation drug contents substances. Mobile A contained mixture Acetonitrile 15 mM Phosphate buffer (pH adjusted to 3.4 with orthophosphoric acid) ratio 20:80. B same 80:20. Chromatographic separation carried out at flow rate 0.8 mL/min using C 18 Phenomenax inplace Enable (250 × 4.6 mm) 5 μm column detection made 254 nm. Results: The linearity tested range 62.5-187.5 μg/mL Hydrochlorothiazide, 100-300 medoxomil, 1-1.8 Hydrochlorothiazide. % recovery found be 99.88-100.67 99.14-99.91 (OLM), 99.11-100.71% (HCTZ-IMP) 98.13-100.83% (OLM-IMP). assay marketed formulation 99.78% (HCTZ) 99.26% (OLM). Conclusion: simple, precise accurate

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