文摘

快速测定氨氯地平besylate、缬沙坦在制剂stability-indicating超高液相色谱法

作者(年代):Yarram Ramakoti Reddy Kakumani基肖尔Kumar M.R.P.Reddy, K.Mukkanti

稳定——指示UPLC法开发的同时定量测定氨氯地平besylate药品剂型、缬沙坦降解产物的存在。它涉及一个50毫米x 4.6毫米,1.8µm C-18列。分离是实现简单的权力平等主义的方法。磷酸二氢钾缓冲的混合物(pH值3.2,0.01 m) -乙腈(比例为55:45,v / v)作为流动相。流量为0.7毫升/分钟和检测波长为237 nm。氨氯地平的保留时间besylate、缬沙坦是0.8分钟,1.3分;分别。总体运行时间是2分钟内活性化合物和降解产物分离。氨氯地平besylate、缬沙坦受到不同我规定压力条件。退化被发现出现在水解应力条件和一定程度上在氧化应激条件下,而药物稳定光解和热应力。 The drugs were particularly labile under acidic stress conditions. The drugs were subjected to stress conditions of hydrolysis, oxidation, photolysis and thermal degradation. The method developed was successfully applied to the simultaneous determination of amlodipine besylate and valsartan in pharmaceutical preparations. The developed RP-UPLC method was validated with respect to linearity, accuracy, precision, robustness and ruggedness.