HPLC法测定盐酸丙酰左卡尼汀原料药及其制剂的含量和有关物质

Determination of Content and Related Substances of Propionyl-L-carnitine Hydrochloride Raw Materials and Its Preparation by HPLC

目的:建立测定盐酸丙酰左卡尼汀原料药及其制剂含量和有关物质的方法。方法:采用高效液相色谱法测定3批盐酸丙酰左卡尼汀原料药及注射用制剂中主成分及杂质A、B、C的含量。色谱柱为Angilent Eclipse XDB-C18,流动相为0·006mol·L-1辛烷磺酸钠溶液(pH3·0)-甲醇(95:5),流速为1·0mL·min-1,柱温为30℃,检测波长为210nm。结果:盐酸丙酰左卡尼汀色谱峰与杂质峰能完全分离,主成分检测浓度线性范围为1·0036～20·072mg·mL-1(r=0·9997);低、中、高浓度平均回收率分别为99·92%、100·62%、100·25%,RSD为1·68%、2·41%、2·12%(n=9);最低检测限为0·03888mg·mL-1;6批样品中总杂质含量均小于1·930%。结论:本法简单、灵敏、专属性强、结果准确,适用于测定盐酸丙酰左卡尼汀原料药及其制剂的含量和有关物质。

OBJECTIVE： To develop a method for the determination of the content and related substances of Propionyl-L-carnitine hydrochloride raw materials and its preparation. METHODS： HPLC method was adopted for the contents of main components and impurity A, B and C in 3 batches of Propionyl-L-carnitine hydrochloride raw material and injections. The separation was performed on Agilent Eclipse XDB-C18 column with mobile phase consisted of 0.006 mol·L-1 octanesulfonic acid sodium solution （pH 3.0）-methanol （95 ∶ 5） at the flow rate of 1.0 mL·min-1. The column temperature was 30 ℃ and the detection wavelength was set at 210 nm. RESULTS： Good separation of propionyl-L-carnitine hydrochloride and impurity peak could be achieved. The linear range of main component was 1.003 6～20.072 mg·mL-1 （r=0.999 7）. The average recoveries of low, medium and high concentrations were 99.92%, 100.62%, 100.25%, RSD were 1.68%, 2.41% and 2.12%, respectively （n=9）. The lowest detection limit was 0.038 88 mg·mL-1. The contents of impurity in 6 batches of samples were lower than 1.930%. CONCLUSION： The established method is simple, sensitive, specific and accurate, and it can be used for simultaneous determination of the content and related substances of Propionyl-L-carnitine hydrochloride raw materials and its preparations.