高效液相色谱法和紫外分光光度计法测定孕酮阴道环体外释药量的比较研究

Study on Comparing HPLC with UV to Determine the Release Quantity of Progesterone Vagina Ring in vitro

目的:比较高效液相色谱(HPLC)法和紫外分光光度计(UV)法测定孕酮阴道环体外释药量。方法:①HPLC法:十八烷基键合硅胶为填充剂,以甲醇∶水(63∶37)为流动相,流速为1.0ml/min,检测波长254nm;②UV法:检测波长254nm。结果:UV法测定释药量均值为9.9μg/ml,相对标准偏差(RSD)4.82%;HPLC法测定释药量均值为10.1μg/ml,RSD2.25%。配对t检验统计结果表明HPLC和UV法的结果没有显著性差异。结论:两种方法均可作为体外释放量的测试方法。

Objective： To compare HPLC with UV to determined the release quantity of progesterone vagina ring in vitro. Methods： 1） HPLC： An ODS column and a mobile phase of methanol-water （63 ： 37） were used. The flow rate was 1.0 ml/min and measuring wavelength was 254 nm; 2） UV：The measuring wavelength was 254 nm. Results： The mean of release quantity was 10.1 μg/ml, RSD was 2.25% by HPLC and the mean of release quantity was 9.9 μg/ml, RSD was 4.82% by UV. Conclusion： There is no remarkable difference between the results of HPLC and UV according statistic conclusion with partnership t test.Two methods can both be used to measure the release quantity of progesterone vagina ring in vitro.