Abstract

Mithun Rudrapal^1*, Madhavi Usharani Oduri¹, Nageswara Rao Samidala¹, B. V. V. S. Surya Kiran², Julfikar Ali Junejo³, Khumantham Deepak Singh³, Tapash Chakraborty³, Manabendra Debnath⁴

DOI : http://dx.doi.org/10.13005/ojc/310236

A simple, precise and accurate RP-HPLC method was developed and validated for simultaneous estimation of olmesartan (OLM) and hydrochlorothiazide (HCT) in tablet dosage form. Separation was achieved on a reversed-phase C-18 column (250x4.6 mm i.d., 5µm) using a mobile phase consisting of methanol/acetonitrile (pH 2.6, 70:30, v/v) at a flow rate of 1.0 mL/min and UV detection at 254 nm. The method was validated as per ICH guidelines for linearity, accuracy, precision and robustness. The developed method shows good linearity over the concentration range of 20-80 µg/mL (r²=0.999) for both olmesartan and hydrochlorothiazide. The average percentage recoveries were in the range of 100.0-100.04% and 100.0-100.06% for olmesartan and hydrochlorothiazide, respectively. The limits of detection (LODs) were 0.04 µg/mL and 0.13 µg/mL for olmesartan and hydrochlorothiazide, and limits of quantification (LOQs) were 0.01 µg/mL and 0.05 µg/mL, respectively. Therefore, the proposed method can be applied for routine analysis of the bulk drugs as well as combined pharmaceutical dosage forms of olmesartan and hydrochlorothiazide.

Olmesartan; Hydrochlorothiazide; Tablet dosage form; RP-HPLC; Validation

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