摘要
目的目的优化国产奥卡西平片含量测定的方法,并对检验数据进行统计分析。方法采用HPLC法。国产奥卡西平片按标检验时,主峰前发现一分离度欠佳的异常峰,对该异常峰的成因进行了讨论后,对方法进行了优化,成功消除了异常峰。结果对优化后的方法进行了方法学验证,50.52~505.20μg·mL^(-1)奥卡西平与峰面积呈良好的线性关系(r=0.9999),平均回收率为101.63%,RSD=0.84%。结论所用方法测定了68批次奥卡西平片中奥卡西平的含量,并对结果进行统计分析。
OBJECTIVE To optimize the content determination method of oxcarbazepine tablets made in China and to analyze the test data.METHODS HPLC method was used.An abnormal peak with poor resolution was found in front of the main peak when the domestic oxcarbazepine tablets were tested according to the standard.RESULTS The causes of the abnormal peak were discussed,the method was optimized and the abnormal peak was successfully eliminated.The results showed that the linear range of oxcarbazepine concentration was 50.52-505.20μg·mL^(-1)(r=0.9999),and the average recovery was 101.63%with RSD=0.84%.CONCLUSION The new method can be used to determine the content of oxcarbazepine in 68 batches of oxcarbazepine tablets,and the results can be statistically analyzed.
作者
张耀元
陈学艳
ZHANG Yaoyuan;CHEN Xueyan(NMPA Key Laboratory for Quality Control of Traditional Chinese Medicine.Tibetan Medicine,Key Laboratory of Modernization of Chinese and Tibetan Medicine in Qinghai Province,Qinghai Provincial Institute for Drug Control and Testing,Xining,Qinghai,810016 P.R.China)
出处
《华西药学杂志》
CAS
CSCD
2022年第1期81-85,共5页
West China Journal of Pharmaceutical Sciences
