盐酸西酞普兰在药物制剂中降解产物和添加剂存在下的分光光度法和化学计量法定量测定

HeshamSalem, MarianneNebsen
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引用次数: 0

摘要

建立了一种简便、准确、灵敏、有效的紫外稳定性指示分光光度法和化学计量法,用于测定盐酸西酞普兰(CitalopramHydrobromide, CT)的碱性、氧化降解产物及其制剂的含量。方法(A)是一种连续导数比分光光度法,它依赖于两步的连续导数比光谱,在277nm和293nm处测量氢溴西酞普兰。方法(B)是比例光谱的平均定心,它依赖于连续两步平均定心比例光谱,并在237nm处测量第二个比例光谱的平均定心值;方法(C)使用了两种化学计量技术;主成分回归(PCR)和偏最小二乘(PLS)。使用实验室配制的混合物对所提出的方法进行了验证,并成功地应用于含有氢溴西酞普兰的药物制剂的分析。根据ICH指南对建议的方法进行了验证。所得结果与药典hplc法测定结果进行了统计学比较,准确度和精密度均无显著差异。
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Quantitative determination of citalopramhydrobromide by spectrophotometry and chemometry in presence of its degradation productsand additives in pharmaceutical preparation
Simple, accurate, sensitive and validated UV stability-indicating spectrophotometric and chemometric methods were developed for determination of CitalopramHydrobromide (CT) in presence of its alkaline, oxidative degradation products and in its pharmaceutical preparation. Method (A) is a successive derivative ratio spectrophotometricone, which depends on the successive derivative of ratio spectra in two steps andmeasuring Citalopram Hydrobromide at 277nmand 293nm.Method (B) ismean centering of ratio spectra which dependson using the mean centered ratio spectra in two successive steps and measuring the mean centeredvalues of the second ratio spectra at 237nm and method (C) used two chemometric techniques ; principal component regression(PCR) and partial least-squares (PLS). The proposed methods werechecked using laboratory-prepared mixtures and were successfully applied for the analysis of pharmaceuticalformulation containing Citalopram Hydrobromide. The proposed methods were validated according to the ICH guidelines. The obtained results were statistically comparedwith those obtained froma compendialHPLCmethod, showing no significant difference with respect to accuracy and precision.
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