Development and Validation of RP-HPLC Method for Simultaneous Estimation of Olmesartan and Hydrochlorothiazide in Tablet Dosage Form

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/ac...

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Bibliographic Details
Published in:Oriental journal of chemistry 2015, Vol.31 (2), p.921-926
Main Authors: Rudrapal, Mithun, Oduri, Madhavi, Samidala, Nageswara, Kiran, B. V. V. S., Junejo, Julfikar, Singh, Khumantham, Chakraborty, Tapash, Debnath, Manabendra
Format: Article
Language:English
Subjects:
Accuracy
Acetonitrile
Chromatography
Dosage
Drug dosages
Flow velocity
Hypertension
International conferences
Laboratories
Linearity
Methods
Pharmaceuticals
Potassium
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Summary: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.
ISSN:0970-020X
2231-5039
DOI:10.13005/ojc/310236