目的 建立藥用輔料乳酸中乳酸的HPLC測定方法。方法 采用高效液相色譜法，使用Capcell Pak C₁₈ MG色譜柱（250 mm×4.6 mm，5μm）；流動相為0.1%磷酸水溶液-乙腈（97.5：2.5）；檢測波長為215 nm，體積流量為1 mL/min；柱溫為35℃；進(jìn)樣量為20 μL。結(jié)果 乳酸在0.1~5.0 mg/mL與峰面積呈良好的線性關(guān)系（r=0.999 9），平均回收率為99.8%，RSD值為0.8%（n=9）。結(jié)論 此方法操作便捷、經(jīng)濟(jì)，方法準(zhǔn)確度、精密度、耐用性好，可作為藥用輔料乳酸中乳酸測定的分析方法。

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

國家藥典委員會藥品標(biāo)準(zhǔn)制修訂研究課題（2019Y046）