高效液相色谱法测定醋酸甲羟孕酮片的含量

目的建立测定醋酸甲羟孕酮片含量的高效液相色谱（HPLC）法。方法色谱柱选用Diamonsil（钻石）C18柱（150mm×4．6mm，5μm），以甲醇-水（65：35）为流动相，流速为1．0mL／min，紫外检测波长为241nm，柱温为40℃，按外标法以峰面积计算醋酸甲羟孕酮的含量。结果醋酸甲羟孕酮质量浓度在0．5～1000μg／mL范围内与峰面积线性关系良好，r=0．99999（n=8）。该方法与内标法及紫外一可见分光光度法含量测定结果一致，RSD=0．39％（n=3）。结论HPLC法简便易行，准确可靠，重现性好，专属性强。

Study on Determination of Medroxyprogesterone Acetate Tablet by HPLC

Objective To develop a HPLC method for the content determination of Medroxyprogesterone Acetate Tablets. Methods The Diamonsil C18 column （150 mm ×4.6 mm, 5 μm） was used with methanol -water（65 ： 35） as the mobile phase,the flow rate was 1.0 mL/min, the UV detective wavelength was 241 nm, and the column temperature was set at 40 ℃, the external calibration curve of peak area was selected. Results The calibration curve was good linear in the range from 0. 5- 1 000. 0 μg/L, r =0. 999 99（ n =8）. Compared with the internal standard method and UV visible speetrophotometry, the result of the content determination was same. RSD was 0. 39% （n=3）. Conclusion The method is simple, accurate, reliable, reproducible and exclusive.