高效液相色谱法测定氯强油搽剂中氯霉素和醋酸泼尼松的含量

Determination of chloramphenicol and prednisone acetate in Luqiangyou liniments by HPLC

目的:建立高效液相色谱法测定氯强油搽剂中氯霉素和醋酸泼尼松的含量。方法:测定氯霉素含量用Spherisorb C18柱(4.6mm×250mm,5μm),流动相为甲醇-0.02mol.L-1磷酸二氢钾(用磷酸调pH至3.0)(60∶40,v/v),流速为0.9mL.min-1,检测波长为242nm;测定醋酸泼尼松含量用C18色谱柱(4.6mm×250mm,5μm),以甲醇-水(60∶40,v/v)为流动相,检测波长为240nm,流速为1.0mL.min-1。结果:氯霉素在100.1~500.4mg.L-1范围内线性关系良好(r=0.999 6),平均回收率为100.2%;醋酸泼尼松在10~150mg.L-1范围内线性关系良好,峰面积积分值与浓度呈良好线性关系(r=0.999 6);平均回收率为99.4%(RSD=1.7%)。结论:高效液相色谱法可以用于该制剂得含量测定和质量控制,方法简便、灵敏、结果准确。

OBJECTIVE To establish an HPLC method for determination of chloramphenicol and Prednisone Acetate in LuQiangYou Liniments.METHODS Chloramphenicol:for C_(18) column(4.6 mm x 250 mm,5 μm) was used;The mobile phase consisted of methanol-(0.02 mol)·L^(1) polassium dihydrogen phosphate solution(pH was adjusted to(3.0) with phosphoric acid)(60∶40,v/v),the flow rate was(0.9 mL)·min^(-1),and the detection wavelength was 242 nm;For prednisone:C_(18) column((4.6 mm) ×250 mm,5 μm)was used with the mobile phase of,methanol-water(60∶40,v/v),the flow rate was(1.0 mL)·min^(-1),and the detection wavelength was 240 nm.RESULTS The linear ranges of chloramphenicol and Prednisone Acetate were within(100.1)-(500.4 mg)·L^(-1)(r=(0.999 6)) and 10-150 mg·L^(-1)(r=(0.999 9)),respectively;the average recoveries were(100.2%)(RSD=(0.2%)) and(99.4%)(RSD=(1.7%)).CONCLUSION This method is simple,accurate,sensitive,and can be used for the quality control.