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目的应用粉末X-射线衍射技术对片剂中阿托伐他汀钙的晶型Ⅰ含量进行定量分析。方法采用缩短扫描范围,降低扫描速度,提高步进扫描时间的精细扫描方法,建立了晶型Ⅰ含量测定的线性方程y=3179.3x?304.56(r=0.992 3),并经方法学验证。结果对2个规格6个批号片剂的晶型Ⅰ含量进行了测定,结果发现片剂中晶型Ⅰ含量有一定的变化。结论本法操作简单,在辅料没有干扰的情况下可用于片剂中阿托伐他汀钙晶型Ⅰ含量的定量分析。
Objective To quantitatively analyze the content of crystalline form I of atorvastatin calcium in tablets by powder X-ray diffraction. Methods The linear equation y = 3179.3x? 304.56 (r = 0.992 3) was established by using the fine scanning method of shortening the scanning range, reducing the scanning speed and increasing the step scanning time. The method was verified by the method. Results The content of Form I in six batches of tablets with two specifications was determined. The results showed that there was a certain change in the content of Form I in tablets. Conclusion The method is simple to operate and can be used for the quantitative analysis of atorvastatin calcium crystal form I in tablets without interference of excipients.