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目的建立HPLC法测定消旋卡多曲片中消旋卡多曲含量的方法。方法采用高效液相色谱法测定,用C_(18)柱(150 mm×4.6mm,5μm),以乙腈-0.02mol/L醋酸铵溶液(用醋酸调节PH值至5.0)(65∶35)为流动相,柱温30℃,流速1.0m L/min,进样体积20μL,检测波长为210nm。结果消旋卡多曲的空白辅料未出现干扰峰;检测限为4.316ng/mL;定量限为10.97ng/mL;线性范围为0.02158mg/m L~0.2003mg/m L,线性关系r=0.99937;回收率为99.7%,RSD=0.9%(n=9);溶液在36小时内峰面积的RSD为0.5%。结论该方法测定消旋卡多曲专属性好,灵敏度高,定量准确,精密度好,线性范围宽,36小时内溶液稳定,适合消旋卡多曲的含量测定。
OBJECTIVE To establish a HPLC method for the determination of racecadotril in racecadotril. Methods High performance liquid chromatography (HPLC) was performed on a C 18 column (150 mm × 4.6 mm, 5 μm) with acetonitrile - 0.02 mol / L ammonium acetate solution (adjusted to pH 5.0 with acetic acid) Mobile phase, column temperature 30 ℃, flow rate 1.0m L / min, injection volume 20μL, detection wavelength of 210nm. Results No interference peak appeared in the blank adjuvant of racecadotril. The detection limit was 4.316ng / mL. The limit of quantification was 10.97ng / mL. The linear range was 0.02158mg / m L ~ 0.2003mg / m L, the linear relationship was 0.99937 ; The recovery was 99.7% with RSD = 0.9% (n = 9); the RSD of the peak area was 0.5% within 36 hours. Conclusion The method has good specificity, high sensitivity, accurate quantification, good precision, wide linear range and stable solution within 36 hours. The method is suitable for the determination of racecadotril.