高效液相色谱法测定醋酸羟丙基甲基纤维素琥珀酸酯中的酰基含量

Determination of Acyl Content in Hydroxypropyl Methylcellulose Acetate Succinate by High Performance Liquid Chromatography

醋酸羟丙基甲基纤维素琥珀酸酯是一种重要的药物肠溶缓释材料,其中的乙酰基和琥珀酰基含量对于产品的功能具有重要影响,因此准确测定这些酰基十分必要。目前,有关该化合物中乙酰基和琥珀酰基含量测定方法存在操作复杂、耗时长、准确性差等许多不足。本文采用高效液相色谱法,使用反相C18型(5μm,250×4.6mm)色谱柱,以0.02mol/L pH=2.8KH2PO4缓冲溶液为流动相,215nm为检测波长进行测定,乙酸和丁二酸在0.03-0.8mg/mL范围内线性关系良好,其线性相关系数分别为R2=0.9992、R2=0.9993,相对标准偏差分别为3.04%、2.32%(n=6),平均加标回收率分别为99.3%、99.4%。该方法操作简便,重现性好,与化学滴定法相比,可得到一致的测定结果。

Hydroxypropyl Methylcellulose Acetate Succinate is an important drug enteric-coated sustained-release material,in which the acetyl and succinyl content has an important impact on the product′s features,so the accurate determination of these acyl is necessary.There are many deficiencies in determination of the acetyl and succinyl groups in recent method,such as complicated to operate,time-consuming,poor accuracy.So a new method of using high performance liquid chromatography（HPLC）is proposed in this article.And the result showed that,Dikma ODS C18 platial（5um,250×4.6mm）was used as column,mobile phase was 0.02mol/L pH=2.8KH 2PO4,and the detection wavelength was at 215 nm,the relationship of acetic acid and succinic acid was good in the range of 0.03-0.8mg/mL,and linear correlation coefficients were 0.9992 and 0.9993,respectively.The Relative Standard Deviation（RSD） of determination results were 3.04% and 2.32%（n=6）,The average recovery were 99.3% and 99.4%.The method is simple,rapid,and has good precision.The results obtained by the present method accord well with those obtained by chemical titration.