HPLC法测定氯诺昔康分散片的含量含量均匀度及溶出度

HPLC Determination of Lornoxicam Content Content Uniformity and Dissolution in Lornoxicam Dispersible Tablets

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 to determine the lornoxicam content,content uniformity and dissolution in lornoxicam dispersible tablets.Methods The analysis was conducted on a KINGFUN-Eldath AQ-C18column（4.6mm×250mm,5μm）using a mobile phase of 0.05mol·L-1 potassium phosphate monobasic solution（1 ml acetic acid added to 100 ml solution）-methonal（50∶50）.The flow rate was 1.0ml·min^（-1）,the column temperature was 30℃and the detection wavelength was 383 nm.Results There was a good resolution rate between the peaks of lornoxicam and the main related substances.There was a good linear relationship between the peak area and the concentration of lornoxicam in the range of 2.84-45.40μg·ml^（-1）.Regression equation could be expressed as A=5.9476×104 C-1.6466×104,r =0.9999（n =6）.The average recovery was 100.47%（RSD=0.79%,n =9）,whihe the RSD of the repeatability test was 0.51%（n =6）.The solution remained stable for 24 h.Conclusion This method is specific,accurate and sensitive,which can be used for quality control of lornoxicam dispersible tablets.