Simultaneous Estimation of Olmesartan medoxomil and Hydrochlorothiazide by RP-HPLC Method in Combined Tablet Dosage Forms and its Invitro Dissolution Assessment.

Authors

  • Kusum Lata Faculty of Pharmacy, Shri Baba Mastnath Institute of Pharmaceutical Sciences and Research, Asthal Bohar, Rohtak-124021
  • Vivek Tomar Matrix Laboratories Ltd.,Hyderabad, India.
  • Vineet Mittal Faculty of Pharmacy, Shri Baba Mastnath Institute of Pharmaceutical Sciences and Research, Asthal Bohar, Rohtak-124021
  • Anil Hooda Faculty of Pharmacy, Shri Baba Mastnath Institute of Pharmaceutical Sciences and Research, Asthal Bohar, Rohtak-124021
  • Pawan Jalwal Faculty of Pharmacy, Shri Baba Mastnath Institute of Pharmaceutical Sciences and Research, Asthal Bohar, Rohtak-124021

Abstract

A simple, sensitive, rapid and reproducible reversed- phase HPLC method has been developed and validated for estimation of Olmesartan medoxomil and Hydrochlorothiazide simultaneously and also the comparative study of invitro data in tablet formulation. The assay involved an isocratic elution of these two component on Inertsil-phenyl column (25cm X 4.6mm, 5µm) using a mobile phase composition of Buffer: Acetonitirile (480:520) and pH adjusted to 3.0 with dilute orthophosphoric acid. The flow rate was 1.0 mL/min and the analytes monitored at 257nm.Calibration curves were linear with coefficient correlation between 0.99 to 1.0 over a concentration range of 24 to 74 µg/mL of Olmesartan medoxomil and 15 to 47 µg/mL for Hydrochlorothiazide respectively. The invitro release of various test units was compared for their similarity using the f2 test which limits were found with in the acceptance criteria. All the validation parameters were with in the acceptance range according to ICH norms. The described method was successfully employed for quality control assay of both the component simultaneously and dissolution data helpful in generating the further information regarding invivo absorption rate in tablet dosage form.

Keywords:

Olmesartan medoxomil, Hydrochlorothiazide, Invitro dissolution study, Reversed-phase HPLC, Antihypertensive agent

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Published

2025-01-01
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Vol. 2 No. 3 (2010): Volume 2,Issue3

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