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目的:建立以高效液相色谱法测定盐酸雷诺嗪缓释片中主药含量的方法。方法:以Kromasil C18为色谱柱,流动相为乙腈-pH7.0的磷酸盐缓冲液(40∶60),检测波长为272nm,流速为1 mL.min-1,柱温为30℃,进样量为20μL。结果:盐酸雷诺嗪在50.22～502.2μg.mL-1(r=0.999 6)范围内有良好的线性关系,平均回收率为100.1%,RSD为0.3%。结论:本方法简便、准确、专属性强,可用于该制剂的质量控制。
Objective: To establish a HPLC method for the determination of the main drug in ranolazine hydrochloride sustained-release tablets. METHODS: Kromasil C18 was used as the mobile phase. The mobile phase was acetonitrile-pH 7.0 phosphate buffer (40:60), the detection wavelength was 272 nm, the flow rate was 1 mL.min-1, the column temperature was 30 ℃, The amount is 20 μL. Results: Ranolazine had a good linear relationship in the range of 50.22 ~ 502.2μg.mL-1 (r = 0.999 6) with an average recovery of 100.1% and a RSD of 0.3%. Conclusion: The method is simple, accurate and specific and can be used for the quality control of the preparation.