高效液相色谱法测定盐酸纳曲酮片的溶出度

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

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 2 40nm。溶出度以转篮法测定 ,转速 10 0r·min-1,溶出介质 0 .0 5mol·L-1盐酸溶液 10 0mL。结果 4.0～ 5 0 .0 μg·mL-1范围线性良好 ,r =0 .9998(n =3) ,平均回收率 99.6 % (n =9) ,RSD =1.2 %。片剂 2 0min定时取样测定 ,主药溶出 90 %以上。结论 该片溶出快而完全 。

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&middotmin-1, and the solvent was 100 mL of 0.05 mol&middotL-1 hydrochloride solution. RESULTS: The linearity of the standard curve was obtained over the range of 4.0∼50.0 μg&middotmL-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.