Abstract

METHOD DEVELOPMENT AND VALIDATION OF SIMULTANEOUS ANALYSIS OF OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE BY UV AND HPLC, THEIR CROSS VALIDATION.

Kuldeep Singh, Anirbandeep Bose*, Gurubasavaraja Swamy PM and Divakar Goli

ABSTRACT

Objective: Development of UV and HPLC method for simultaneous estimation of Olmesartan Medoxomil (OLM) and Hydrochlorothiazide (HCTZ) and validation of developed method. UV method development was done by Q-Absorbance ratio method using methanol as solvent. The main reason behind the concern of this analysis is its cost effectiveness, due to high cost of analytical reagent mainly HPLC GRADE solvent. Sometimes companies cannot afford to provide drugs at lower cost. In literature survey analysis of many antihypertensive combination drugs are analyzed by HPLC and UV. Most of the studies are not well validated and not cross validated by other methodology. Method: Absorption maxima method based on the measurement of absorbance at 225nm. Results: method obey Beer- Lamberts law in concentration range of 2-10μg/ml for HCTZ and 2-20 μg/ml for OLM. Methods were validated as per ICH guidelines in terms of accuracy, linearity and precision. Conclusion: The proposed methods found to be simple, accurate, precise, reproducible, economic and suitable for routine quality control analysis. Gradient mobile phase system was used for estimation of drug contents .Mobile phase A contained the mixture of Acetonitrile and Methanol (1:1) and Mobile phase B 15 mM Phosphate buffer (pH adjusted to 3.0 with orthophosphoric acid) in the ratio of 50:50. Chromatographic separation was carried out at the mobile phase flow rate of 1.0 ml/min using C18. Results: The linearity of developed method was tested in the range of 4-25 μg/mL for Hydrochlorothiazide, 12-25 μg/ml for Olmesartan Medoxomil, 2-10 μg/Ml for HCTZ,2-20 μg/ml for OLM by HPLC and UV respectively. The % recovery was found to be 99.79-99.83 % (HCTZ), 102% (OLM), and 99.69-99.70 %( HCTZ), 99.89-99.93 %( OLM) by UV and HPLC respectively. The assay of marketed formulation was found to be 102% (HCTZ) and 96% (OLM). Phenomenax inplace of Enable (250 × 4.6 mm) 5 μm column and detection was made at 257 nm. Conclusion: A simple, precise and accurate UV, RP-HPLC method was developed for determination of Hydrochlorothiazide, Olmesartan Medoxomil.

Keywords: Hydrochlorothiazide (HCTZ), Olmesartan Medoxomil (OLM).Reversed phase high performance liquid chromatography (RP-HPLC).