HPLC测定盐酸洛美利嗪胶囊的含量及有关物质

Determination of Content and Related Substances of Lomerizine Hydrochloride in Capsule by HPLC

关键词:  盐酸洛美利嗪  含量测定  有关物质  高效液相色谱法

Key words:  lomerizine hydrochloride  content determination  related substances  HPLC

摘要:

目的 建立盐酸洛美利嗪胶囊的含量测定及有关物质检查方法。方法 采用高效液相色谱法，色谱柱为Diamonsil-ODS柱(4.6 mm×150 mm，5 μm)，以乙腈-0.001 mol·L^-1十二烷基硫酸钠溶液(60∶40)为流动相，流速1.0 mL·min^-1，柱温35 ℃，波长225 nm。结果 盐酸洛美利嗪与各主要杂质及强制破坏产生的降解产物的杂质峰均分离良好，盐酸洛美利嗪在17.04~153.40 mg·mL^-1内与峰面积呈良好线性关系，r=1.000，回收率为99.8% (RSD=1.12%，n=9)，供试品溶液在24 h内稳定。结论 本法专属性强，结果准确，方法灵敏可靠，可用于盐酸洛美利嗪的含量测定和有关物质检查。

Abstract:

OBJECTIVE To establish a method to determine the content and related substances of lomerizine hydrochloride capsule. METHODS HPLC was adopted on a Diamonsil-ODS column (250 mm×4.6 mm, 5 μm) using an isocratic mobile phase consisted of acetonitrile-0.001 mol·L^-1 SDS (60∶40) with a flow rate of 1.0 mL·min^-1. The column temperature was kept at 35 ℃ and the detection wavelength was set at 225 nm. RESULTS Lomerizine hydrochloride and its related impurities could be separated effectively. The concentration-response relationship was linear over the range of 17.04-153.40 mg·mL^-1(r=1.000). The average recovery was 99.8%(RSD=1.12%, n=9). The solution was stable for 24 h. CONCLUSION The method is specific, accurate, sensitive and suitable for the determination of content and related substances of lomerizine hydrochloride.