Development and Validation of Spectrophotometric Methods for Simultaneous Estimation of Valsartan and Hydrochlorothiazide in Tablet Dosage Form

M. Jadhav, M. V. Girase, Shripad K. Tidme, M. S. Junagade
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引用次数: 16

Abstract

Two UV-spectrophotometric methods have been developed and validated for simultaneous estimation of valsartan and hydrochlorothiazide in a tablet dosage form. The first method employed solving of simultaneous equations based on the measurement of absorbance at two wavelengths, 249.4 nm and 272.6 nm, for valsartan and hydrochlorothiazide, respectively. The second method was absorbance ratio method, which involves formation of Q-absorbance equation at 258.4 nm (isoabsorptive point) and also at 272.6 nm ( of hydrochlorothiazide). The methods were found to be linear between the range of 5–30 µg/mL for valsartan and 4–24 μg/mL for hydrochlorothiazide using 0.1 N NaOH as solvent. The mean percentage recovery was found to be 100.20% and 100.19% for the simultaneous equation method and 98.56% and 97.96% for the absorbance ratio method, for valsartan and hydrochlorothiazide, respectively, at three different levels of standard additions. The precision (intraday, interday) of methods was found within limits (). It could be concluded from the results obtained in the present investigation that the two methods for simultaneous estimation of valsartan and hydrochlorothiazide in tablet dosage form are simple, rapid, accurate, precise and economical and can be used, successfully, in the quality control of pharmaceutical formulations and other routine laboratory analysis.
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分光光度法同时测定片剂中缬沙坦和氢氯噻嗪含量的建立与验证
建立并验证了两种紫外分光光度法同时测定片剂剂型缬沙坦和氢氯噻嗪的含量。第一种方法采用求解联立方程的方法,分别测量缬沙坦和氢氯噻嗪在249.4 nm和272.6 nm两个波长处的吸光度。第二种方法是吸光度比法,在258.4 nm处(等吸收点)和272.6 nm处(氢氯噻嗪)建立q -吸光度方程。以0.1 N NaOH为溶剂,缬沙坦的测定范围为5 ~ 30 μg/mL,氢氯噻嗪的测定范围为4 ~ 24 μg/mL。缬沙坦和氢氯噻嗪在三种不同添加水平下,联立方程法的平均回收率分别为100.20%和100.19%,吸光度法的平均回收率分别为98.56%和97.96%。方法的精确度(日内、日间)均在限定范围内()。本研究结果表明,同时测定缬沙坦和氢氯噻嗪片剂剂型的方法简便、快速、准确、精密度高、经济,可成功地用于制剂的质量控制和其他常规实验室分析。
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