盐酸贝尼地平片溶出度的测定

Dissolution Determination of Benidipine Hydrochloride Tablets

目的:建立盐酸贝尼地平片溶出度的测定方法。方法:根据《中国药典》2005年版溶出度测定方法第三法(小杯法),以0.1mo·lL^(-1)盐酸为介质,转速为50r·min^(-1),于30min时取样,采用紫外分光光度法在359nm波长处测定吸光度,并计算累积溶出度。结果:盐酸贝尼地平检测浓度线性范围为5～30μg·mL^(-1)(r=0.9999);平均回收率为99.76%,RSD=0.47%;3批样品30min时累积溶出度均在80%以上。结论:所建立的溶出度方法简单、可靠,可用于盐酸贝尼地平片溶出度的测定。

OBJECTIVE：To establish a method for the dissolution determination of Benidipine hydrochloride tablets.METHODS：According to Chinese Pharmacopeia（2005 edition）,Benidipine hydrochloride tablets were added into hydrochloride acid 0.1 mol·L^-1 at rotation speed of 50 r·min^-1,then samples were obtained after 30 min.The absorbance of samples was detected at detection wavelength of 359 nm and accumulative dissolution was calculated.RESULTS：The linear range of benidipine hydrochloride was 5～30μg·mL-1（r=0.999 9）with an average recovery of 99.76%（RSD=0.47%）.The accumulative dissolutions of 3 batches of samples were all above 80%.CONCLUSIONS：Established method is simple and reliable for the dissolution determina-tion of Benidipine hydrochloride tablets.