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目的建立测定盐酸曲马多缓释片中盐酸曲马多含量的高效液相色谱(HPLC)法。方法色谱柱为KR100C18柱(250mm×4.6mm,5μm),流动相为庚烷磺酸钠与磷酸二氢钾混合液(庚烷磺酸钠1.02g与磷酸二氢钾0.68g,加水500mL溶解)-甲醇-三乙胺(45∶55∶0.1),流速为1.0mL/min,柱温为25℃,检测波长为271nm,进样量为20μL。结果盐酸曲马多质量浓度线性范围为10～250μg/mL(r=0.9999),深圳厂产品的平均回收率为99.8%(RSD为0.48%),上海厂产品平均回收率为100.1%(RSD为0.70%)。结论HPLC法简便、准确、快速、灵敏,测定结果准确。
Objective To establish a high performance liquid chromatography (HPLC) method for the determination of tramadol hydrochloride in tramadol hydrochloride sustained-release tablets. Methods The column was a KR100C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of a mixture of sodium heptane sulfonate and potassium dihydrogen phosphate (1.02 g sodium heptane sulfonate and 0.68 g potassium dihydrogen phosphate and dissolved in 500 mL water) - methanol - triethylamine (45:55:0.1) at a flow rate of 1.0mL / min. The column temperature was 25 ℃, the detection wavelength was 271nm and the injection volume was 20μL. Results The linear range of tramadol hydrochloride concentration was 10 ~ 250μg / mL (r = 0.9999), the average recovery rate of Shenzhen factory products was 99.8% (RSD 0.48%), and the average recovery rate of Shanghai factory products was 100.1% (RSD 0.70%). Conclusion HPLC method is simple, accurate, rapid, sensitive and accurate.