HPLC法分析非PVC软包装氟康唑注射液中的有关物质

Determination the related substances in non-PVC Fluconazole Injection by HPLC

目的建立非PVC软包装氟康唑注射液有关物质的HPLC方法并进行方法学研究。方法采用C18色谱柱，以pH7.0磷酸盐缓冲液-甲醇（55：45）为流动相，流速为0．9mL·min^-1，柱温30℃，检测波长260nm。结果线性范围为5～15μg·mL^-1，回归方程Y=1．31×10^3X-4．85×10^2，r=0．9997，最低检测限为0．7μg·mL^-1（S／N=3），精密度RSD为0.9％，稳定性RSD为0．6％。结论本法简便、易行、灵敏度高，适用于非PVC软包装氟康唑注射液有关物质分析。

OBJECTIVE An HPLC method had been developed for the non-PVC Fluconazole Injection related substances. METItODS A YWG-C18 column was used. The mobile phase was pH7.0 buffer phosphatic-methanol（55 ： 45） ,the flow rate was 0. 9μg·mL^-1 and column temperature was 30℃ ,the detection wavelength was 260nm. RESULTS The linear range was 5～15μg·mL^-1, the calibration curve regress equation was Y = 1.31 × 10^3 X -4.85 × 10^2 , with a correlation coefficient of 0.9997, the limit of detection was 7μg·mL^-1 （S/N = 3）, precision RSD was 0.9%, stability RSD was 0.6% . CONCLUSION This method was accurate simple and quick ,it was can be used on the analysis of non-PVC Fluconazole Injection related substance.