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目的建立一种凝胶剂的样品前处理方法,并结合HPLC法测定硫酸阿托品眼用凝胶中硫酸阿托品的含量。方法采用中空纤维离心超滤的前处理手段有效地除去样品溶液中羟丙甲纤维素高分子辅料后,用HPLC法测定含量。采用Phenomenexc C_(18)色谱柱(250 mm×4.60 mm,5μm),流动相为甲醇-50 mmol·L~(-1)磷酸盐缓冲溶液(35∶65,用磷酸调pH3.5),流速1.0 mL·min~(-1),检测波长217 nm。结果 10.4~52.0μg·mL~(-1)硫酸阿托品与峰面积的线性关系良好(r=0.9997),回收率为99.9%~100.6%,RSD<2%,测得硫酸阿托品含量为标示量的99.5%~100.2%。结论所用方法操作简便、结果准确,可用于硫酸阿托品眼用凝胶的含量分析。
OBJECTIVE To establish a sample pretreatment method for gels and to determine the content of atropine sulfate in ophthalmic gels of atropine sulfate by HPLC. Methods The content of hypromellose macromolecule extender in the sample solution was effectively removed by the pretreatment method of hollow fiber centrifugal ultrafiltration. The content was determined by HPLC. A Phenomenexc C 18 column (250 mm × 4.60 mm, 5 μm) was used with a mobile phase of methanol-50 mmol·L -1 phosphate buffer (35:65, adjusted to pH 3.5 with phosphoric acid) at a flow rate 1.0 mL · min ~ (-1), the detection wavelength was 217 nm. Results The linear range of the peak area was 10.4 ~ 52.0μg · mL -1 (r = 0.9997), the recovery was 99.9% ~ 100.6% and the RSD was less than 2%. The atropine sulfate content was the labeled amount 99.5% ~ 100.2%. Conclusion The method is simple, accurate and can be used for the analysis of atropine sulfate eye gel.