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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∶0.067 mol.L-1磷酸二氢钾(20∶40∶40,V/V/V)(pH 3.8),检测波长210 nm,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1.2~150 mg.L-1(r=0.999 9)和4.0~12.0 mg.L-1(r=0.999 9),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、D 4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。
OBJECTIVE To establish a HPLC method for the simultaneous determination of clarithromycin and its related substance A, and to determine and compare the contents of 5 clarithromycin tablets, related substance A and dissolution rate. Methods Diamonsil C18 column was used. The mobile phase consisted of methanol: acetonitrile: 0.067 mol·L-1 potassium dihydrogen phosphate (pH = 3.8) Prednisolone; Determination of the dissolution rate of clarithromycin tablets by the spin basket method. Results The linear ranges of clarithromycin and its related substances were 1.2-150 mg.L-1 (r = 0.999 9) and 4.0-12.0 mg.L-1 (r = 0.999 9) respectively. The RSDs were 1.5% and 0.9% %, The average recovery of clarithromycin was 99.3%; A, B, C, D 4 kinds of clarithromycin tablet content and dissolution are in line with the requirements, E does not comply; B related substances content is the lowest. Conclusion The determination method is simple and reliable. Plant B can better control the content of related substance A in the product.