拉西地平及片剂含量的测定方法及其稳定性的研究

 目的：建立拉西地平及其片剂的质量分析方法，并考察其稳定性。方法：采用高效液相色谱法对拉西地平及其片剂进行定量测定。以尼莫地平为内标物，甲醇-水（80∶20）为流动相，NOVA-Pack C₁₈柱（3．9mm×150mm），检测波长283nm，流速0．8ml·min^－1。结果：此法线性范围6μg·ml^－1～66μg·ml^－1，r＝0．9999，n＝6，平均回收率为100．6％，RSD＝0．89％（n＝7）。结论：此方法内标物尼莫地平对拉西地平及其片剂的测定无干扰。测定方法灵敏度高，重现性好，可作为拉西地平及其片剂的质量控制方法。拉西地平对光不稳定，对热相对稳定，对湿度稳定。

Determination and stability of lacidipine and its tablets by HPLC

OBJECTIVE: To establish a quality analysis method for lacidipine and its tablets, and to study its stability. METHOD: Lacidipine and its tablets were determined by high performance liquid chromatograph. Chromatographic conditions were: mobile phase: methanol-water (80∶20); internal standard: nimodipine; column size: NOVA-Pack C₁₈ (3.9 mm×150 mm); flow rate: 0.8 ml·min^-1; and the detection wave length was set at 283 nm. RESULTS: The method was linear within the range of 6 μg·ml^-1～66 μg·ml^-1 (r=0.999 9, n=6), the average recovery for the assay was 100.6% and RSD was 0.89% (n=7). CONCLUSION: The method is sensitive and highly reproducible and it can be used for the quantitative determination of lacidipine and its tablets. Lacidipine was sensitive to light, relatively sensitive to heat and not sensitive to humidity.