高效液相色谱法测定胶囊中异维A酸含量及其均匀度

Determination of isotretinoin content and contentuniformity in capsules by high performance liquid chromatography

目的建立胶囊中异维A酸含量及其含量均匀度的高效液相色谱测定方法,为胶囊中异维A酸含量及含量均匀度质量标准提高提供可靠实验依据与技术支持。方法样品经甲醇溶解稀释后测定。分离柱为UltimateXB-C_(18)(4.6 mm×250 mm,5μm),流动相为甲醇-水-冰乙酸(770/255/5,V/V/V),检测波长为355 nm。结果方法线性范围为0.003μg/L^0.018μg/L,线性相关系数r=0.999 6,RSD为0.96%(n=6);样品平均回收率为99.6%。结论通过测定结果比较了现行新版药典(《中国药典》2015年版二部)中规定的紫外-可见分光光度法与高效液相色谱法之间的优缺点,高效液相色谱法测定胶囊中异维A酸含量及含量均匀度具有更强的专属性,同时准确度与精密度均良好,可以用于胶囊中异维A酸含量及含量均匀度的测定,并为推动该品种药品质量标准的提升提供了十分重要的理论与实践意义。

Objective To establish a method for the determination of isotretinoin and its uniformity in capsules by high performance liquid chromatography（ HPLC）,so as to provide reliable experimental basis and technical support for improving quality inspection standard. Methods After dissolved and diluted with methanol,separation was performed on a C_（18） column with a mobile phase of methanol,water and glacial acetic acid（ 770/225/5,V/V/V）. The detection wavelength was set as 355 nm.Results The linear range of the method was 0. 003 μg/L-0. 018 μg/L and the correlation coefficient was 0. 999 6. The relative standard deviation（ RSD） was 1. 34%（ n = 6） and the average recovery was 99. 6%. Conclusion On the basis of measurement results,the advantages and disadvantages of the UV-visible spectrophotometric method and high performance liquid chromatography in the current new edition of Pharmacopoeia（ China Pharmacopoeia 2015 edition Section 2） were compared.The high performance liquid chromatography method had more advantage in the detection of isotretinoin content and its uniformity in capsules. The specificity of isotretinoin content and uniformity is more specific. At the same time,the accuracy and precision are both good. It can be used to determine the content and uniformity of isotretinoin in capsules,and it has very important theoretical and practical significance for promoting the quality standards of the isotretinoin.