复方氨酚烷胺胶囊(片)胆红素的含量考察

Determination of Bilirubin in Compound Paracetamol and Amantadine Hydrochloride Capsules(Tablets)

目的 采用高效液相色谱法(HPLC)考察复方氨酚烷胺胶囊(片)中胆红素的含量.方法 以十八烷基硅烷键合硅胶为填充剂(4.6 mm×250 mm,5μm);以甲醇-三氯甲烷-1%磷酸溶液(81:13:6)为流动相;检测波长为449 nm.结果 胆红素线性范围为3.17-47.56μg/ml(r=0.9996,n=5),平均加样回收率为100.7%,RSD为1.5%.测定28个厂家生产的61批次复方氨酚烷胺样品,结果3个厂家8批次胆红素含量偏低.结论 应完善质量标准,增加制剂中人工牛黄中胆红素含量测定方法.

Objective To determine the content of bilirubin in Compound Paracetamol and Amantadine Hydrochloride Capsules(Tablets)by HPLC.Methods Octadecylsilane bonded silica gel was used as filler(4.6 mm×250 mm,5μm).The mobile phase was methanol-trichloromethane-1%phosphoric acid solution(81:13:6).The detection wavelength was 449 nm.Results The linear range of bilirubin was 3.17-47.56μg/ml(r=0.9996,n=5).The average recovery was 100.7%,with RSD of 1.5%.61 batches of samples from 28 factories were determined.The bilirubin content in 8 batches of samples from 3 factories was low.Conclusion The quality standard should be improved,and the content of bilirubin in artificial bezoar in the preparations should be determined.