目的 建立药用辅料乳酸中乳酸的HPLC测定方法。方法 采用高效液相色谱法，使用Capcell Pak C₁₈ MG色谱柱（250 mm×4.6 mm，5μm）；流动相为0.1%磷酸水溶液-乙腈（97.5：2.5）；检测波长为215 nm，体积流量为1 mL/min；柱温为35℃；进样量为20 μL。结果 乳酸在0.1~5.0 mg/mL与峰面积呈良好的线性关系（r=0.999 9），平均回收率为99.8%，RSD值为0.8%（n=9）。结论 此方法操作便捷、经济，方法准确度、精密度、耐用性好，可作为药用辅料乳酸中乳酸测定的分析方法。

Objective To establish an HPLC method for assay of lactic acid in pharmaceutical excipient lactic acid. Methods HPLC method was adopted. The determination was carried out on Capcell Pak C₁₈ MG C₁₈ column (250 mm×4.6 mm, 5 μm). The mobile phase was consisted of 0.1% phosphoric acid aqueous solution-acetonitrile (97.5:2.5). The detection wavelength was set at 215 nm. The flow rate was 1.0 mL/min. The column temperature was 35℃, and volume of injection was 20 μL. Results The linear relation was good (r=0.999 9) between lactic acid and peak area in the range of 0.1-5.0 mg/mL. The average recovery rate was 99.8% with RSD values of 0.8% (n=9). Conclusion The method has simple operation, good accuracy, precision and durability, which can be performed in assay of lactic acid in pharmaceutical excipient lactic acid.

R927.2

国家药典委员会药品标准制修订研究课题（2019Y046）