RP-HPLC法测定氨酚待因缓释胶囊中磷酸可待因和对乙酰氨基酚的含量

目的测定氨酚待因缓释胶囊 (PCSRC)中磷酸可待因和对乙酰氨基酚的含量。方法采用反相高效液相色谱法进行测定。流动相为 5 0mmol·L-1磷酸二氢钾溶液 (磷酸调节 pH值至 4 0 ) 甲醇 四氢呋喃 (V∶V∶V =80 0∶10 0∶37 5 ) ,检测波长为 2 80nm ,流速为 1mL·min-1。结果RP HPLC法测定磷酸可待因和对乙酰氨基酚的线性范围分别为 0 0 2 36～ 0 2 36 0 g·L-1和 0 2 5 77～2 5 77g·L-1,方法回收率分别为 10 0 3%和 10 0 1% ,RSD分别为 0 2 9%和 0 5 2 %。结论该法灵敏、准确、重现性好 ,可以满足氨酚待因缓释胶囊的质量控制要求。

Determination of codeine phosphate and paracetamol in paracetamol and codeine phosphate sustained-release capsules by RP-HPLC

Objective To determine the contents of codeine phosphate and paracetamol in PCSRC.Methods The reverse-phase HPLC method was used on a Hypersil ODS C 18 column with 50 mmol·L -1 KH 2PO 4 (adjusted to pH 4.0 with H 3PO 4)-methanol-tetrahydrofuran (V∶V∶V =800∶100∶37.5) as the mobile phase and 280 nm as the detection wavelength.The flow rate was set at 1.0 ml·min -1.Results The linear ranges of codeine phosphate and paracetamol were 0.023 6～ 0.236 0 g·L -1 and 0.257 7～ 2.577 g·L -1respectively.The recoveries of the method of codeine phosphate and paracetamo were 100.31% (RSD=0.29%) and 100.06%(RSD=0.52%),respectively.Conclusion The HPLC method established is sensitive,accurate and reproducible,and could satisfy the demand of quality control of paracetamol and codeine phosphate sustained-release capsules.