目的 高效液相色谱法测定奥沙普秦胶囊的溶出度,为质量控制提供依据。方法 参照《中国药典》(2020年版二部)、日本橙皮书和美国药典收载的奥沙普秦片和奥沙普秦肠溶胶囊的标准,对奥沙普秦胶囊的溶出度进行方法学研究,建立测定奥沙普秦溶出度的高效液相色谱法(HPLC)。结果 HPLC分析条件色谱柱Inertsil C8(250 mm×4.6 mm;5 μm)为固定相;0.1%磷酸(pH 2.0)-乙腈(55∶45)为流动相;流速1.0 ml/min;检测波长286 nm,柱温35 ℃;进样体积20 μl。溶出方法:0.05 mol/l磷酸二氢钾缓冲液(pH 7.4)1000 ml为溶出介质, 篮法,转速100 r/min,溶出时间45 min,限度75%。结论 建立的奥沙普秦胶囊溶出方法和HPLC测定方法,具有较好的专属性、精密度和准确度,可作为奥沙普秦胶囊溶出度质量标准依据。
Abstract
Objective To determine the dissolution rate of Oxaprozin capsules by high performance liquid chromatography, and to provides the basis for the quality control. Methods According to the Standard of oxaprozin tablets and oxaprozin enteric-coated capsules in the Chinese Pharmacopoeia (2020,partII),Japanese Orange Book and the United States Pharmacopoeia,we methodologically validated the dissolution method of oxaprozin capsules,and established a method for dissolution determination of oxaprozin capsules by HPLC. Results An HPLC method was used, and the saparation was performed on a Inertsil C8(250 mm×4.6 mm;5 μm) column with the mobile phase consisting of 0.1% phosphoric acid solution- acetonitrile(55∶45) at a flow rate of 1.0 ml/min. The column temperature was 35 ℃.The Injection volume was 20 μl. The dissolution test was performed by basket method with 0.05 mol/l Monopotassium phosphate buffer solution (pH7.4) of 1000 ml as dissolution medium and rotating speed of 100 r/min, dissolution time 45 minutes, limit 75%. Conclusions The estsblished method of dissolution determination by HPLC showed good specificity,precision and accuracy, and can be used as the basis for the dissolution quality standard of oxaprozin capsules.
关键词
奥沙普秦胶囊 /
高效液相色谱法 /
溶出度
Key words
oxaprozin capsules /
high performance liquid chromatography /
dissolution
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