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目的建立氯诺昔康分散片含量、含量均匀度及溶出度的HPLC测定法。方法采用RH-HPLC法,色谱柱为KINGFUN-Eldath AQ-C18(4.6mm×250mm,5μm),流动相:0.05mol·L-1磷酸二氢钾溶液(每100ml加1ml冰醋酸)-甲醇(50∶50),流速为1.0ml·min~(-1),柱温:30℃,检测波长:383nm。结果氯诺昔康峰与各主要杂质峰分离度良好,氯诺昔康在2.84~45.40μg·ml~(-1)范围内与峰面积线性关系良好,回归方程为A=5.9476×104 C-1.6466×104,r=0.9999(n=6);平均加样回收率为100.47%,RSD为0.79%(n=9);重复性试验RSD为0.51%(n=6);供试品溶液在24h内稳定。结论本方法准确、灵敏、专属性强,适用于氯诺昔康分散片的质量控制。
Objective To establish an HPLC method for the determination of lornoxicam dispersible tablets, content uniformity and dissolution. Methods The mobile phase was KINGFUN-Eldath AQ-C18 (4.6 mm × 250 mm, 5 μm) with a mobile phase of 0.05 mol·L -1 potassium dihydrogen phosphate (1 ml glacial acetic acid per 100 ml) by using RH-HPLC. 50:50), flow rate 1.0ml · min -1, column temperature 30 ℃, detection wavelength 383nm. Results The lornoxicam peak was well separated from the major impurity peaks. Lonoxicam had a good linear relationship with the peak area in the range of 2.84 ~ 45.40μg · ml ~ (-1), the regression equation was A = 5.9476 × 104 C- 1.6466 × 104, r = 0.9999 (n = 6). The average recovery was 100.47% and the RSD was 0.79% (n = 9). The repeatability test RSD was 0.51% (n = 6) 24h stable. Conclusion The method is accurate, sensitive and specific. It is suitable for the quality control of lornoxicam dispersible tablets.