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

被引：10

作者：

Rudrapal, Mithun ^{[1
]}

Oduri, Madhavi Usharani ^{[1
]}

Samidala, Nageswara Rao ^{[1
]}

Kiran, B. V. V. S. Surya ^{[2
]}

Junejo, Julfikar Ali ^{[3
]}

Singh, Khumantham Deepak ^{[3
]}

Chakraborty, Tapash ^{[3
]}

Debnath, Manabendra ^{[4
]}

机构：

[1] Aditya Inst Pharmaceut Sci & Res, Surampalem, AP, India

[2] Koringa Coll Pharm, Tallarevu M, AP, India

[3] Dibrugarh Univ, Dept Pharmaceut Sci, Dibrugarh, Assam, India

[4] S Vivekananda Mahavidyalaya, Dept Human Physiol, Mohanpur, Tripura, India

来源：

ORIENTAL JOURNAL OF CHEMISTRY | 2015年 / 31卷 / 02期

关键词：

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

D O I：

10.13005/ojc/310236

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

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., 5 mu m) 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 mu g/mL (r(2)=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 mu g/mL and 0.13 mu g/mL for olmesartan and hydrochlorothiazide, and limits of quantification (LOQs) were 0.01 mu g/mL and 0.05 mu g/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.

引用

页码：921 / 926

页数：6

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