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目的 建立那格列奈顺反式异构体分离测定的HPLC。方法 采用C18柱 ,在室温下 ,以 (A)乙腈 (B) 0 .0 3mol·L-1磷酸盐缓冲液 (pH 2 .5 ) (6 5∶35 )为流动相 ,检测波长 2 14nm ,进样量 10 μL。结果 那格列奈顺反式异构体的分离度大于 1.5 ,最小检出限为 0 .0 6 μg·mL-1,定量限为 0 .18μg·mL-1。结论 本法可有效分离测定顺式体。
OBJECTIVE To establish a HPLC method for the separation and analysis of the cis-isomers of nateglinide. Methods The mobile phase was C18 column with (A) acetonitrile (B) 0. 3mol·L-1 phosphate buffer (pH 2.5) Injection volume 10 μL. Results The separation of nateglinide trans isomer was greater than 1.5, the minimum detection limit was 0.06 μg · mL-1, and the limit of quantification was 0.18 μg · mL-1. Conclusion This method can effectively separate and determine cis-form.