高效液相色谱法测定普伐他汀钠胶囊的溶出度
高效液相色谱法,,普伐他汀钠；普伐他汀钠胶囊；溶出度；高效液相色谱法,1仪器与试药,2方法与结果,3讨论,参考文献：
摘要：目的采用高效液相色谱法测定普伐他汀钠胶囊的溶出度。方法按照《中国药典》2000年版Ⅱ部溶出度测定法中的第二法，以水900 ml为溶剂，转数为50 r·min-1，30 min时采样。采样后以高效液相色谱法测定。色谱柱：DiamonsilTM C18(200 mm×4.60 mm，5μm)，流动相：磷酸盐缓冲液甲醇(40∶60)pH 3.5±0.05，流速：1.0 ml· min-1 , 检测波长：238 nm，以外标法测定普伐他汀钠胶囊的溶出度。结果线性范围为3.0～12.0 μg·ml-1 (r=0.999 9)。平均回收率为99.86%，(RSD=1.7%，n=6), 溶出度符合规定。结论该方法简便、易行，结果准确。关键词：普伐他汀钠；普伐他汀钠胶囊；溶出度；高效液相色谱法
HPLC Determination of Dissolution of Pravastatin Sodium Capsule
XIE Hua
(Livzon (Group)Pharmaceutical Factory,Zhuhai, Guangdong 519020, China)
Abstract:ObjectiveTo establish an HPLC method for detecting dissolution of Pravastatin Sodium capsule.MethodsAccording to Appendix XC II of Chinese Pharmacopoeia 2000 edition Vol II, dissolution medium was 900 ml of water and rotating speed was 50 r·min-1.After 30 min the dissolution solution of the capsule was taken and analyzed by HPLC method. A DiamonsilTMC18 (5 μm, 200 mm×4.60 mm),using the mobile phase of methanol - phosphate buffer solution(60∶40) pH 3.5±0.05,at a flow rate of 1.0 ml·min-1 and the detection wavelength of 238 nm.ResultsThe linear range of Pravastatin Sodium was 3.0～12.0 μg·ml-1(r=0.999 8).The average recovery of Pravastatin Sodium was 99.86%(RSD=1.7%,n=6).The result of dissolution of the capsule meets the requirement.ConclusionThis Method is rapid, simple and accurate. ......
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