盐酸氯吡格雷片溶出度方法研究

目的:建立盐酸氯吡格雷片溶出度测定方法。方法:根据《中国药典》2010年版溶出度测定方法中的第二法(桨法),以0.1mol·L-1盐酸溶液为溶出介质,转速为50r·min-1,于30min时取样,采用紫外分光光度法在波长270nm处测定吸光度并计算溶出度。结果:盐酸氯吡格雷检测浓度线性范围为50～320μg·mL-1(r=0.9998);平均回收率为99.46%,RSD=0.57%;3批样品溶出度30min时均在85%以上。结论:建立的溶出度测定方法准确、简便,可用于测定盐酸氯吡格雷片的溶出度。

Study on the Determination Method for Dissolution Rate of Clopidogrel Hydrochloride Tablets

OBJECTIVE： To establish the determination method for the dissolution rate of Clopidogrel hydrochloride tablets. METHODS： According to the second determination method of dissolution rate （paddle method） stated in Chinese Pharmacopeia （2010 edition）, the dissolution rate and absorbency of the sample was calculated using 0.1 mol·L^-1 hydrochloric acid solution as the solvent at the rotation speed of 50 r·min^-1 at 30 min and detection wavelength of 270 nm. RESULTS： The linear range of clopidogrel hydrochloride was 50-320 μg·mL^-1 （r=0.999 8） with an average recovery of 99.46% （RSD=0.57%）. The dissolution rate of 3 batches of samples was more than 85% at 30 min. CONCLUSION： The method is simple and accurate for the dissolution determination of Clopidogrel hydrochloride tablets.