摘要
目的建立同时测定克拉霉素及其相关物质A的HPLC法，并对5种克拉霉素片剂的含量、相关物质A及溶出度进行测定和比较。方法采用Diamonsil C18色谱柱，流动相为甲醇：乙腈：0．067mol·L^-1磷酸二氢钾（20：40：40，V/V/V）（pH3．8），检测波长210nm，内标为泼尼松龙；采用转篮法测定克拉霉素片剂的溶出度。结果克拉霉素及其相关物质的线性范围分别为1．2—150mg·L^-1（r=0．9999）和4．0-12．0mg·L^-1（r=0．9999），RSD分别为1．5％和0．9％，克拉霉素的平均加样回收率为99．3％；A、B、C、D4种克拉霉素片剂含量和溶出皆符合要求，E不符合；B的相关物质含量最低。结论测定方法简便可靠，B厂能较好地控制产品中相关物质A的含量。
AIM To establish HPLC method to determine the clarithromycin and clarithromycin related compound A in the preparations, then to compare the two substances＇ concentration and the dissolution of five clarithromycin tablets from different manufacturers. METHODS The HPLC analysis was carried out on the C18 column. The mobile phase was methanol-acetonitrile-0.067 mol·L^-1 monobasic potassium phosphate（20 ： 40 ： 40, V/V/V） . The detective wavelength was 210 nm. The internal standard was prednisolone. The dissolution of clarithromycin was obtained by using of the rotating basket method. RESULTS The linear range of clarithromycin and clarithromycin related compound A was 1.2 - 150 mg·L^-1（r =0.999 9） and 4.0- 12.0 mg·L^-1（r =0.999 9）, respectively. The RSD（with-in group） was 1.5% and 0.9%, respectively. The average recovery of clarithromycin was 99.3%. The contents of clarithromycin and the dissolution of product A, B, C and D fitted the standard. The product E didn＇ t. The content of clarithromycin related compound A of product B was the lowest. CONCLUSION The method is convenient and feasible. The manufacturer B has a best way to control the content of clarithromycin related compound A of the tablet.
出处
《中国临床药学杂志》
CAS
2009年第3期160-163,共4页
Chinese Journal of Clinical Pharmacy
