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首页> 外文期刊>American Journal of Analytical Chemistry >Stability Indicating RP-HPLC Method for Estimation of Impurities of Vitamin D3 Analogue and Corticosteroid Used as Antipsoriatic Drugs. An Attempt to Characterize Pre-Calcipotriene
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Stability Indicating RP-HPLC Method for Estimation of Impurities of Vitamin D3 Analogue and Corticosteroid Used as Antipsoriatic Drugs. An Attempt to Characterize Pre-Calcipotriene

机译：RP-HPLC的稳定性指示方法可用于估计用作抗银屑病药物的维生素D3类似物和皮质类固醇的杂质。表征前钙三碳烯的尝试

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摘要

A single RP-HPLC method is developed for estimation of isomeric impurities of vitamin D3 analogue-Calcipotriol/Calcipotriene (Calci) and impurities of Betamethasone dipropionate (BD). The developed method is capable of separating impurities of Calci and BD, specifically pre-Calcipotriene (Pre-Calci) from other known and unknown impurities. Pre-Calci is isolated and is characterised using few analytical techniques. These impurities are separated using a RP-C18 150 × 4.6 mm, 2.7 μm column maintained at 50°C. The mobile phase consisted of mixture of water, methanol, acetonitrile and tetrahydrofuran eluted in gradient mode. Detection was done at 264 nm and 240 nm for Calci and BD impurities respectively. The method can be used for determining quality of Calci and BD drugs and ointment based drug products. It is stability indicating related substance method for both the drugs and drug products.
机译：开发了一种单一的RP-HPLC方法，用于估算维生素D3类似物-钙三醇/钙三烯（Calci）和倍他米松二丙酸酯（BD）的异构杂质。所开发的方法能够从其他已知和未知杂质中分离出Calci和BD的杂质，特别是Cal-Calcipotriene（Pre-Calci）。 Pre-Calci是分离的，并且使用很少的分析技术来表征。使用保持在50°C的RP-C18 150×4.6 mm，2.7μm色谱柱分离这些杂质。流动相由水，甲醇，乙腈和四氢呋喃的梯度洗脱液组成。分别在264 nm和240 nm处检测Calci和BD杂质。该方法可用于确定Calci和BD药品以及基于软膏的药品的质量。它是用于药品和药品的稳定性指示相关物质方法。

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