本文建立了一种用于新药那格列奈片含量测定的稳定性指示HPLC法 ,并对方法的选择性、准确性、精密度、检测限和定量限等进行了认证。采用C18色谱柱 ,以乙腈 甲醇 磷酸盐缓冲液 (70 :4 :12 0 ,v v v ,pH 6 6 )为流动相 ,流速为 1 0mL·min- 1 ,检测波长为 2 16nm。线性范围为 4 94 - 4 9 9μg·mL- 1 (r=0 9999,n =5 ) ,平均回收率为 99 9(RSD =0 5 % ,n =9) ,精密度为 0 3% (n =6 )。本法选择性好、准确度高 ,可用于那格列奈片的含量测定。 In this paper, a HPLC method was established for the determination of nateglinide in new drugs. The selectivity, accuracy, precision, limit of detection and limit of quantification of the method were also verified. The mobile phase was acetonitrile-methanol-phosphate buffer (70: 4: 12 0, vv v, pH 6 6) with a C18 column with a flow rate of 10 mL · min-1 and a detection wavelength of 2 16 nm. The linear range was 94-49 9 μg · mL -1 (r = 0 9999, n = 5) with an average recovery of 99 9 (RSD = 0.5%, n = 9) with a precision of 0 3% (n = 6). This method has good selectivity and high accuracy and can be used for the determination of nateglinide tablets.