A new and rapid analytical method development & validation for simultaneous estimation of hydrochlorothiazide, amlodipine & olmesartan in tablet dosage form by using RP-HPLC

S. Ashutosh Kumar, Manidipa De

Abstract

In the present work a new and accurate RP-HPLC method was developed and validated for simultaneous estimation of Hydrochlorothiazide, Amlodipine & Olmesartan in bulk drug and in combined dosage forms. The HPLC separation was achieved on a Symmetry C18 (4.6 X 150mm, 5µm, Make: XTerra) or equivalent in an Isocratic Mode. The mobile phase was composed of TEA Buffer (40%) whose pH was adjusted to 3.5 by using Ortho Phosphoric Acid & Acetonitrile (60%) [HPLC Grade]. The flow rate was monitored at 0.8ml per min. The wavelength was selected for the detection was 230 nm. The run time was 9min. The retention time found for the drugs Hydrochlorothiazide, Amlodipine & Olmesartan were 3.034 min., 4.062 min. & 5.165 min. respectively. The % recovery was found to be 99.3- 101.7 for Hydrochlorothiazide. The % recovery was found to be 98.3 - 99.3for Amlodipine. The % recovery was found to be 98.3 - 100.7 for Olmesartan. The linearity was established in the range of 25 to 62.5ppm for Hydrochlorothiazide & 10 to25ppm for Amlodipine & 10 to100 ppm for Olmesartan. The LOD for Hydrochlorothiazide, Amlodipine & Olmesartan were found to be 0.009µg/ml, 0.06µg/ml & 0.06µg/ml respectively. The LOQ for Hydrochlorothiazide, Amlodipine & Olmesartan were found to be 0.03µg/ml, 0.2µg/ml & 0.2µg/ml respectively. The proposed method was adequate sensitive, reproducible and specific for the determination of Hydrochlorothiazide, Amlodipine & Olmesartan in bulk as well as in tablet dosage form. The method was simple, precise, accurate and sensitive and applicable for the simultaneous determination of Hydrochlorothiazide, Amlodipine & Olmesartan in bulk drug and in combined dosage forms.

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