反相高效液相色谱法测定克林霉素磷酸酯注射液的稳定性

Reversed phase high pressure liquid chromatography method for determination of stability of clindamycin phosphate

目的 :建立测定克林霉素磷酸酯的反相高效液相色谱分析法 ,考察不同厂生产的注射液的稳定性。方法 :LichrosorbC18色谱柱 (150mm× 4 .6mm ,5μm ) ,流动相为 30mmol·L- 1盐酸三乙胺(pH =2 .6 5) :乙腈 (80 :2 0V/V ) ,流速 1.0mL·min- 1,检测波长 2 10nm。结果 :Y =5970 75c -6 2 541.8(r =0 .9997,n =5,线性浓度为 0 .4 - 1.6g·L- 1) ,平均方法回收率为 98.9% ,日内、日间精密度RSD %均 <5%。所抽查的 4种产品在对光的稳定性上不存在明显的优劣之分 ,但样品 1,4与样品 2 ,3在对热稳定性上存在差异。结论 :本方法简便、准确、灵敏 ,可用于克林霉素磷酸酯的测定。克林霉素磷酸酯注射液对光稳定 。

AIM:To establish a reversed-phase high pressure liquid chromatography(HPLC) method to determine the concentration of clindamycin phosphate and to investigate the stability of its injections. METHODS: Lichrosorb C 18 colum (150 mm × 4.6 mm, 5 μm )was used with the mobile phase of triethylamine chlorhydric acid solution (30mmol·L -1 ,pH=2.65)∶acetonitrile being 80∶20(V/V),flow rate of 1.0 mL·min -1 and detection wave lenth of 210 nm. RESULTS: The standard curve equation was y =597075c-62541.8( r =0.9997, n =5).The linear range was 0.4 - 1.6g·L -1 . The average recovery rate was 98.9 %.The intra day and inter day precision rate were less than 5 %.There was no difference between four products from different factories with respect to their stabilities to the light, whereas there was a few difference between the sample 1,4, and sample 2, 3, with respect to their stabilities to the heat. CONCLUSION: The RP-HPLC method was simple, rapid and sensitive. The clindamycin phosphate injection is stabilized to the light, but not stabilized to the heat.