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目的采用HPLC法测定盐酸乐卡地平片的溶出度。方法按《中国药典》2010年版溶出度测定第二法,以含0.3%吐温80的0.1 mol·L-1盐酸500 m L为溶出介质,转速为50 r·min-1,45 min时采样。采样后用HPLC法测定,色谱柱为Sun Fire C18,流动相为0.15 mol·L-1高氯酸钠溶液(p H3)-乙腈(39∶61),柱温30℃,流速1.0 m L·min-1,检测波长240 nm,以外标法测定溶出度。结果盐酸乐卡地平2.036~40.72μg·m L-1与峰面积的线性关系良好(r=0.999 9),平均回收率为100.2%,RSD=0.98%(n=9),溶出度符合规定。结论所用方法专属性强、结果准确、稳定性好,适于盐酸乐卡地平溶出度的测定。
Objective To determine the dissolution of lercanidipine hydrochloride tablets by HPLC. Methods According to the second edition of Chinese Pharmacopoeia (2010 edition), 0.1mol·L-1 HCl containing 0.3% Tween 80 was used as the dissolution medium and the sample was taken at 50 r · min-1 and 45 min . The sample was determined by HPLC after the column was Sun Fire C18 with a mobile phase of 0.15 mol·L-1 sodium perchlorate (p H3) -acetonitrile (39:61) at a column temperature of 30 ° C and a flow rate of 1.0 mL · min-1, the detection wavelength was 240 nm, and the dissolution rate was determined by external standard method. Results The linear range of peak area was 2.036 ~ 40.72 μg · m L-1 for lecaedine hydrochloride (r = 0.999 9). The average recovery was 100.2% and the RSD was 0.98% (n = 9). Conclusion The method used has the advantages of specificity, accurate result and good stability, and is suitable for the determination of the dissolution of lercanidipine hydrochloride.