盐酸左旋沙丁胺醇的HPLC测定

Determination of levalbuterol hydrochloride by HPLC

目的 建立了HPLC测定盐酸左旋沙丁胺醇含量及有关物质的方法。方法 采用Chirex(S)-ICA and(R)NEA New Column手性柱,以正已烷-二氯甲烷-甲醇-三氟乙酸(240:140:20:1)为流动相,流速为1.0 mL·min-1,检测波长为278 nm。结果 盐酸左旋沙丁胺醇与杂质分离良好,在0.004-0.8 nag·mL-1范围内峰面积与进样浓度呈良好线性关系(r=0.999 8),日内、日间RSD均小于1.5％,最低检测量为0.8 ng,最低定量限为2.5 ng。结论该法精密、准确,可用于盐酸左旋沙丁胺醇含量及有关物质的测定。

OBJECTIVE: To develep a simple, accurate and reproducible HPLC method for the determination of the levalbuterol hydrochloride. METHODS: Chirex(5)-ICA and (R)NEA New Column was used with N-hexane-dichloromethane-methanol- trifluotoacetic acid (240 :140:20:1) as the mobile phase. The flow rate was 1.0 mL&middotmin-1, the UV detection wavelength was at 278 nm. RESULTS: A satisfactory separation was obtained between levalbuterol hydrochloride and related substances. The calibration curve was linear in the range of 0.004-0.8 mg&middotmL-1 for levalbuterol hydrochloride with good corelation coefficient (r = 0.999 8). The relative standard deviation (RSD) of intra-run and inter-run were both less than 1.5%, the determination limlngit was 0.8 ng and the quantitation limit was 2.5 ng. CONCLUSION: This HPLC assay was simple and quick with high sensitivity, and will be used for the determination of levalbuterol hydrochloride in pharmaceuticals.