HPLC法同时测定复方乳酸左氧氟沙星烧伤凝胶中两组分的含量

Content Determination of Two Components in Compound Levofloxacin Lactate Burn Gel by HPLC

目的:建立同时测定复方乳酸左氧氟沙星烧伤凝胶中乳酸左氧氟沙星和盐酸达克罗宁两组分含量的方法。方法:采用高效液相色谱法。色谱柱为Dionex C18柱,流动相为乙腈-0.015 mol/L磷酸二氢钾溶液(含0.3%三乙胺,用磷酸调pH至3.0。梯度洗脱),流速为1 ml/min,检测波长为284 nm,柱温为30℃,进样量为20μl。结果:乳酸左氧氟沙星和盐酸达克罗宁检测质量浓度分别在3.98～23.88、8.00～48.00μg/ml范围内与峰面积积分值呈良好的线性关系(r=0.999 9、0.999 9);精密度、稳定性、重复性试验的RSD≤0.62%;平均加样回收率分别为99.36%、98.78%,RSD分别为0.71%、0.51%(n=9)。结论:该方法快速、简便、准确,可用于复方乳酸左氧氟沙星烧伤凝胶的质量控制。

OBJECTIVE： To establish a method for the content determination of levofloxacin lactate and dyclonine hydrochlo- ride simultaneously in Compound levofloxacin lactate bum gel. METHODS： HPLC method was adopted. The determination was performed on Dionex C18 column with mobile phase consisted of acetonitrile-0.015 moFL potassium dihydrogen phosphate solution （containing 0.3% trithylamine, pH value adjusted to 3.0 with phosphoric acid, gradient elution） at the flow rate of 1 ml/min. The detection wavelength was set at 284 rim, and column temperature was 30 ℃. The injection volume was 20 μl. RESULTS： The linear range of levofloxacin lactate and dyclonine hydrochloride were 3.98-23.88 μg/ml （r=0.999 9） and 8.00-48.00 μg/ml （r=0.999 9）, respectively. RSDs of precision, stability and reproducibility tests were all lower than 0.62%. The average recoveries were 99.36% （RSD=0.71%, n=9） and 98.78% （RSD=0.51%, n=9）, respectively. CONCLUSIONS： The method is rapid, simple and accu- rate, and it can be used for the quality control of Compound levofloxacin lactate bum gel.