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首页> 外文期刊>Der Pharma Chemica: journal for medicinal chemistry, pharmaceutical chemistry and computational chemistry >Stability-Indicating LC Method for Analysis of Zaltoprofen in Bulk Drug Formulations
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Stability-Indicating LC Method for Analysis of Zaltoprofen in Bulk Drug Formulations

机译：扎洛洛芬在散装药物制剂中的稳定性指示LC方法

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A simple, rapid, and precise LC method has been developed for quantitative analysis of Zaltoprofen (ZLT) in pharmaceutical Bulk dosage forms. Chromatographic separation of ZLT and its degradation products was achieved on a C18 analytical column with 0.01 M Potassium dihydrogen phosphate – acetonitrile, 80:20 (v/v), as mobile phase. The flow rate was 1.0 mL min−1, the column temperature 25 °C, and detection was by absorption at 233 nm using a photodiode-array detector and UV detector. The tailing factor for ZLT was 1.07. ZLT was exposed to thermal, photolytic, hydrolytic, oxidative stress conditions as per ICH guidelines and were analysed by use of the proposed method. Peak homogeneity data for ZLT in the chromatograms from the stressed samples, obtained by use of the photodiode-array detector, demonstrated the specificity of the method for analysis of ZLT in the presence of the degradation products. The linearity of the method was excellent over the range 10–140 μg mL−1 ZLT. The correlation coefficient was 0.9999. Relative standard deviations of peak areas from six measurements were always less than 2%. Each analysis required no longer than 10 min. The proposed method was found to be suitable, stability indicating and accurate for quantitative analysis of ZLT in bulk drug samples and also study its stability.
机译：已经开发了一种简单，快速，精确的液相色谱方法，用于定量分析药物散装剂型中的扎洛洛芬（ZLT）。 ZLT及其降解产物的色谱分离是在C18分析柱上进行的，流动相为0.01 M磷酸二氢钾-乙腈，比例为80:20（v / v）。流速为1.0 mL min-1，柱温为25°C，使用光电二极管阵列检测器和UV检测器通过在233 nm处吸收进行检测。 ZLT的拖尾因子为1.07。根据ICH指南，ZLT暴露于热，光解，水解，氧化应激条件下，并使用提出的方法进行了分析。通过使用光电二极管阵列检测器获得的来自应力样品的色谱图中ZLT的峰均一性数据证明了在降解产物存在下分析ZLT的方法的特异性。该方法的线性在10–140μgmL-1 ZLT范围内极佳。相关系数为0.9999。六次测量的峰面积相对标准偏差始终小于2％。每次分析不超过10分钟。结果表明，所提出的方法适用于散装药物样品中ZLT的定量分析，是合适，稳定的指示方法和准确方法，并且还可以研究其稳定性。

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