高效液相色谱法测定黄体酮注射液的有关物质

目的：建立高效液相色谱法测定黄体酮注射液有关物质。方法：采用Agela Venusil C8（4．6mm×250mm，5μm）色谱柱，甲醇-乙腈-水（25：35：40）为流动相，流速1．5ml／min，检测波长241nm，柱温40℃，自身对照法。结果：其最大杂质峰不超过对照溶液主峰面积的1／2（0．5％），有关物质的峰面积之和不超过对照溶液主峰面积的2倍（2．0％）。结论：本方法能灵敏、准确、可靠的进行杂质检测，对黄体酮注射液有关物质的控制有一定的意义。

Determination of related substances in pregesterone injection by HPLC

Objective： To establish an HPLC method for the determination of the related substances in Pregesterone Injection. Method： The chromatographic system consisted of Agela Venusil Cs （4.6 mm × 250 mm, 5 μm）column as stationary phase and methanol-acetontrile-water（25： 35： 40） as mobile phase. The flow rate of mobile phase is 1.5 ml/min, and the detection wavelength at 241 nm under ambient temperature of 40 ℃. Results： The total peak area of related impurities in Pregesterone Injection＇ was not 2 times greater than that of the dominant peak of the control solution; the largest peak area of related impurity in Pregesterone Injection＇ was less than half the greatest peak area of the control solution. Conclusion： The proposed method is accurate, sensitive and suitable for determination of the related substances of Pregesterone Injection.