衍生化HPLC法测定双氢睾酮制剂中的药物含量

Determination of Dihydrotestosterone in Its Preparations by Column Derivatization HPLC

建立了双氢睾酮制剂中的药物含量测定方法。以对硝基苯甲酰氯为衍生化试剂对双氢睾酮进行柱前衍生,用HPLC法对衍生物进行测定,色谱条件为:ZORBAX SB-C_(18)色谱柱(4.4 mm×250 mm,5μm),甲醇-0.2%三乙胺水溶液(95:5)为流动相,流速1.0 mL·min^(-1),检测波长254 nm,柱温25℃。结果显示建立双氢睾酮制剂中药物的柱前衍生测定法,衍生物线性回归方程为:Y=84517X-29.878(r=0.9997),在4.12~82.40μg·mL^(-1)范围内线性关系良好。衍生化HPLC法准确、灵敏度高,可用于双氢睾酮制剂中药物的含量测定。

An column derivatization HPLC method for determining the contents of dihydrotestosterone preparations was established.The dihydrotestosterone was benzoylated by paranitrobenzoyl chloride as derivatizing reagent,and derivatives of dihydrotestosterone were determined by HPLC.A ZORBAX SB-C_(18) column(4.6 mm×250 mm,5μm)was used with the mobile phase of methanol-0.2%phosphoric acid(95:5)at the detection wavelength of 254 nm,with 1.0 mL·min^(-1)as flow rate and 35℃as column temperature.Results showed that the linear regression equation of derivatives of dihydrotestosterone was Y=84517X-29.878(r=0.9997).The content of derivatives of dihydrotestosterone showed a good linearity with in the range of 4.12~82.40μg·mL^(-1).The established column derivatization HPLC method was accurate and sensitive,can be used for determining the content of dihydrotestosterone preparations.