高效液相色谱法测定盐酸纳曲酮片的溶出度

 目的 测定盐酸纳曲酮片的溶出度。方法 采用高效液相色谱法测定含量，检测波长240 nm。溶出度以转篮法测定，转速100 r·min^-1，溶出介质0.05 mol·L^-1盐酸溶液100 mL。结果 4.0～50.0 μg·mL^-1范围线性良好，r＝0.999 8(n＝3)，平均回收率99.6%(n=9)，RSD=1.2%。片剂20 min定时取样测定，主药溶出90%以上。结论 该片溶出快而完全，溶出速率较美国杜邦公司同类产品略快。

A HPLC method for the determination of dissolution of naltrexone hydrochloride tablets

OBJECTIVE To determine the drug content and dissolution of naltrexone hydrochloride tablets (NHT).METHODS A high performance liquid chromatography method (HPLC) was used with the detection wavelength at 240 nm.A basket method was used to study the dissolution,the rotative velocity was 100 r·min^-1,and the solvent was 100 mL of 0.05 mol·L^-1 hydrochloride solution.RESULTS The linearity of the standard curve was obtained over the range of 4.0～ 50.0 μg·mL^-1, r=0.999 8,n= 3.The average recovery of assay was 99.6% with a relative standard deviation of 1.2%( n =9).The drug dissolution for 20 min was over 90%.CONCLUSION The method was sensitive and accurate.The dissolution of NHT was rapid and complete.The dissolution was faster than that of imported NHT.