论文部分内容阅读
本文报道可测定单个片剂中左旋甲状腺素钠含量均匀度的方法,降解产物及赋形剂对测定无干扰。步骤:精密秤取相当于左旋甲状腺素钠片剂粉末100μg 于具塞试管中,加玻璃珠及流动相[乙腈-水-磷酸(40∶60∶0.05)]10ml,激烈混和5min,离心,上清液进样100μl。用Zorbax-CN 柱,流速1～2ml/min;洗脱液于225nm 波长处测定。用外标法进行测定计算。片剂含量均匀度测定时,按上制备样品,25～150μg剂型用流动相10ml 提取;175～300μg 剂型则用流动相20ml 提取。结果:用美国药典标准左旋甲状腺素制备1～13μg/ml 8份标准液,以峰面积对浓度作标准曲线,相关系数为0.999。作者以25μg 及300μg 作为标示量,于
This article reports a method for determining the evenness of levothyroxine sodium in a single tablet without degradation of the products and excipients. Steps: Precision scales take equivalent to 100g of L-thyroid sodium tablet powder in a stopper tube, add glass beads and mobile phase [acetonitrile - water - phosphoric acid (40:60:0.05)] 10ml, intense mixing 5min, centrifuged, and Serum injection 100μl. With Zorbax-CN column, flow rate 1 ~ 2ml / min; eluent at 225nm wavelength determination. Calculation with external standard method. Tablet content uniformity determination, press the sample preparation, 25 ~ 150μg dosage form with mobile phase 10ml extraction; 175 ~ 300μg dosage form is extracted with mobile phase 20ml. Results: Eight standard solutions of 1 ~ 13μg / ml were prepared with the standard pharmacopoeia of the United States Pharmacopoeia. The calibration curve was calculated by the peak area. The correlation coefficient was 0.999. The author with 25μg and 300μg as the labeled amount, at