盐酸依托必利原料药和剂型分光光度法的建立与验证

S. U. Zate, P. Kothawade, Jitendra W Gajbe, Anantwar S. Pramod, S. Boraste
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引用次数: 16

摘要

建立了一种简便、准确、经济的分光光度法测定原料药和片剂中盐酸依托普利的含量。在0.1N HCl介质中,使用工作波长为258nm的紫外-可见双光束分光光度计进行鉴定。该方法在分析介质中的特异性、线性范围、准确度和精密度进行了验证。盐酸依托必利在258 nm处的吸光度最大(λmax),在5 ~ 100 mcg/ml浓度范围内相关性良好,回收率为96.80 ~ 106.84%,相对标准偏差为0.293 ~ 3.98%。对数据的统计处理表明,该方法精密度高,准确度高,适用于原料药和制剂中盐酸依托必利的含量测定。关键词:光谱光度测量的;Itopride盐酸盐;验证。
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Spectrophotometric method development and validation of itopride hydrochloride in bulk and dosage form
A simple, precise and economical spectrophotometric method for the estimation of Itopride hydrochloride in pharmaceutical bulk and tablet dosage form was developed and validated. Identification was carried out using a UV-visible double beam spectrophotometer detector with working wavelength at 258nm in 0.1N HCl medium. The method was validated with respect to its specificity, linearity range, accuracy, and precision in analytical media. Itopride hydrochloride show the maximum absorbance (λmax) at 258 nm, Regression analysis showed good correlation in the concentration range 5-100 mcg/ml and 96.80 to 106.84% recovery with relative standard deviation 0.293 to 3.98%. Statistical treatment of data reflects that the proposed method is precise, accurate and easily applicable for determination of Itopride hydrochloride in bulk and pharmaceutical preparation. Keywords: Spectrophotometric; Itopride hydrochloride; Validation.
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