氨苯蝶啶片溶出度试验方法的建立

Analysis and dissolution evaluation of triamterene tablets

目的:建立氨苯蝶啶片溶出度试验方法,考察了101批氨苯蝶啶片的溶出度。方法:采用浆法,以pH1.2溶液为溶出介质,转速为50 r.min-1,溶出液相色谱条件:Waters SunFire C18(4.6 mm×150 mm,5μm)色谱柱,丁胺-乙腈-甲醇-水(2∶180∶180∶640),用乙酸调至pH=5.3为流动相;检测波长为358 nm,流速1.0 mL.min-1,进样量5μL。结果:氨苯蝶啶在0.25～99.3μg.mL-1范围内呈现良好的线性关系,r=0.99999,采用此法检测5个厂家101批样品溶出度,35%批次的溶出结果在标准限度以下。结论:溶出试验方法更能体现药品的生物利用度,溶出液测定方法准确、重现性好、操作简单,对全国样品考察结果显示,方法能够有效控制产品的内在质量。

Objective：To establish a test method for the dissolution of triamterene tablets.And we inspected the determination of 101 batches of triamterene tablets in the country.Methods：The method of dissolution was apparatus 2,the medium was hydrochloric acid solution（7→1000） containing 2 g sodium chloride,and rotate speed was 50 r · min-1.And the chromatographic condition of column was Waters SunFire C18（5 μm,4.6 mm×150 mm） column,the mobile phase consisted of butylamine,acetonitrile,methanol,water（2∶ 180∶ 180∶ 640）,adjusted to pH 5.3 with acetic acid,the wavelength of UV detector was 358 nm;the flow rate was 1.0 mL·min-1,the injection volume was 5 μL.Results：The calibration curve was liner in the concentration range of 0.25-99.3 μg · mL-1 r=0.99999;One hundred and one batches samples of five factory were detected using this method and the batches whose results below limit were about 35% in total.Conclusion：The dissolution test method shows more biological availability than before,and the assay method is accurate,highly specific and widely applicable.Through the investigation of samples from the whole country,it is shown that the method developed on this study can be applicable to all the samples and effectively control the internal-quality of product.