高效液相色谱法测定可待敏缓释胶囊的释放度

HPLC Method for Determining Releasing Rate of Codeine Phosphate and Chlorphenamine Maleate Sustained- Release Capsule

目的建立测定复方制剂可待敏缓释胶囊释放度的高效液相色谱法。方法按照2010年版《中国药典（二部）》释放度测定法中的第一法，以水900mL为介质，转速为10017／rain，分别在l，4，8h时采样，以高效液相色谱法测定。色谱柱为DiamonsilC18柱（150mm×4．6mm，5μm）；流动相为0．05mol／L磷酸二氢钾，加入0．01％的己烷磺酸钠溶液（离子对试剂）和0．5％三乙胺，用磷酸调pH至6．0，与甲醇以（50：55）的比例配成流动相并调节pH至7．0～7．5；流速为1．0mL／min；检测波长为220nm。结果可待敏缓释胶囊在12h内缓慢释放，在12h时释放较完全。结论该方法简便，结果准确可靠。

Objective To establish a HPLC method for determining the release rate of Codeine Phosphate and Chlorphenamine Maleatc Extended- Release Capsule. Methods According to the second method of the releasing rate determination mathods in the Chinese Phannacopoeia（edtion 2000,Vol. lI）,with water of 900 mL as the medium and the rotation rate of 100 r/min,sampling was performed at 1,4,8 h respectively and detected by the HPLC method. The chromatographic column was Diamonsil Cts（150 mm × 4.6 mm,5μm）. The mobile phase was 0.05 mol/L KH2PO4 [adding 0.01% sodium hexanesulfonate solution（ion pairing agent） and 0.5% triethylamine,adujusting to pH 6 with phosphoric acid]-methanol（50：55） with pH 7.0-7.5. The flow rate was 1.0 mL/min. The wavelength of detection was 220 nm. Results Codeine Phosphate and Chlorphenamine Maleate Sustained- Release Capsule was slowly released within 12 h and released completely at 12 h. Conclusion The method is simple,rapid,accurate and reliable in the detection results.