Stress degradation studies of hydrochlorothiazide and development of validated method by UV spectroscopy

D. Velmurugan
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Abstract

To develop a simple, precise, accurate, and stability indicating a UV-method for estimation of Hydrochlorothiazide(HCT)in bulk and formulated dosage form.The drug was alsosubjected to stress degradation at different conditions recommended by the International Conference on Harmonization (ICH). The samples are generated and used for the degradation studies.The λmax of the HCTwas found to be 273nm.The linearity of calibration curve (Absorbance Vs Concentration) in pure solution was checked over the concentration ranges of about 5-30μg/mLwith the correlation coefficient higher than 0.99. The regression equation of the curve was Y = 0.598x + 0.0042.% RSD was found to be within the limit as per ICH guidelines. The obtained percentage recovery of HCTwas found to be within the limit100% ± SD.  Stress degradation studies revealed thatitwas within the limit(5-20%).
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氢氯噻嗪的应力降解研究及紫外光谱验证方法的建立
建立一种简便、精确、准确、稳定指示的紫外法测定散装和配方氢氯噻嗪(HCT)的含量。该药物还在国际协调会议(ICH)推荐的不同条件下进行了应力降解。生成样品并用于降解研究。hct的λmax为273nm。在5 ~ 30μg/ ml的浓度范围内,检验了纯溶液中吸光度与浓度的线性关系,相关系数大于0.99。曲线回归方程为Y = 0.598x + 0.0042。RSD在ICH指南规定的范围内。所得的hct回收率在限定范围内(100%±SD)。应力退化研究表明,这是在限制(5-20%)。
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