离子对RP-HPLC法同时测定复方盐酸二甲双胍缓释片中盐酸二甲双胍和马来酸罗格列酮的含量

目的建立复方盐酸二甲双胍缓释片中盐酸二甲双胍和马来酸罗格列酮的含量测定方法。方法色谱柱为DiamonsilTMC18,流动相为10 mmol.L-1KH2PO4和5 mmol.L-1SDS的水溶液(磷酸调pH为3.5)-乙腈(体积比为51∶49),流速为1.0 mL.min-1,检测波长0~5 min为260 nm,5 min之后变为245 nm。以外标法计算复方盐酸二甲双胍缓释片中盐酸二甲双胍和马来酸罗格列酮的含量。结果盐酸二甲双胍的质量浓度在50.02~175.10 mg.L-1内,马来酸罗格列酮在0.530~1.855 mg.L-1内,与峰面积成良好的线性关系,相关系数分别为0.999 7和0.999 4。平均回收率分别为100.1%(RSD=0.80%)和99.56%(RSD=1.8%)。结论辅料不干扰主药测定,该方法可用于复方盐酸二甲双胍缓释片中药物含量测定。

Simultaneous determination of metformin hydrochloride and rosiglitazone maleate in compound metformin hydrochloride sustained- release tablets by ion-paired RP-HPLC

Objective To develop an HPLC method for simultaneous determination of metformin hydrochloride and rosiglitazone maleate in compound metformin hydrochloride sustained- release tablets．Methods The Chromatographic conditions were as follows：Diamonsil^TMC₁₈ (5 μm，200 mm×4.6 mm) column；mobile phase：10 mmoL&;#8226;L^-1 KH₂PO₄ buffer containing 5mmoL&;#8226;L^-1 SDS（ pH was adjusted to 3.5 with orthophosphoric acid）and acetonitrile in the ratio of 51:49；flow rate：1.0ml●min^-1; detection wave1ength: 260 nm 0-5 min, 245nm after 5 min. The contents of metformin hydrochloride and rosiglitazone maleate were calculated by external standard method. Results The calibration curve was linear over the range of 50.02~175.1 mg&;#8226;L^-1 with a correlation coefficient of 0.9997 (n=6) for metformin hydrochloride, and 0.53~1.855 mg&;#8226;L^-1 with a correlation coefficient of 0.9994 (n=6) for rosiglitazone maleate. The average recovery was 100.1% with RSD of 0.80%, 99.56% with RSD of 1.8%, for metformin hydrochloride and rosiglitazone maleate respectively. Conclusions The determination is not interfered by excipients. The method is applicable to simultaneous determination of metformin hydrochloride and rosiglitazone maleate in compound metformin hydrochloride sustained- release tablets．