Nanda R K, Pangarkar V B, Thomas A B, Kothapalli L P, Pawar A A
Department of Pharmaceutical Chemistry, Pad. Dr. D. Y. Patil Institute of Pharmaceutical Science and Research, Pimpri, Pune - 18.
Hindustan Antibiot Bull. 2007;49-50(1-4):29-33.
Two simple, rapid, accurate and precise methods have been developed for simultaneous estimation of Montelukast sodium and Bambuterol hydrochloride from tablet dosage form. In the first method, the first derivative spectrum was determined. Montelukast sodium showed zero crossing point at 209.5 nm and Bambuterol hydrochloride showed zero crossing point at 238.5 nm. The dA/dlambda was measured at 209.5 nm for Bambuterol hydrochloride and 238.5 nm for Montelukast sodium and calibration curves were plotted as dA/dlambda versus concentration respectively. Quantitative determination of Montelukast sodium and Bambuterol hydrochloride in tablets was carried out using calibration curve by interpolation method. In the second method, Multicomponent mode of analysis was used and the measurement of absorbances at two wavelengths, 283.6 nm (lambda-max of MKST) and 211.8 nm (working wavelength selected for BHC) in 95% methanol, was carried out. These methods were validated statistically as per ICH guidelines. The recovery studies confirm the accuracy of the proposed method.
已开发出两种简单、快速、准确且精密的方法，用于同时测定片剂剂型中的孟鲁司特钠和盐酸班布特罗。在第一种方法中，测定一阶导数光谱。孟鲁司特钠在209.5 nm处显示零交叉点，盐酸班布特罗在238.5 nm处显示零交叉点。分别在209.5 nm处测定盐酸班布特罗的dA/dlambda以及在238.5 nm处测定孟鲁司特钠的dA/dlambda，并分别绘制dA/dlambda对浓度的校准曲线。采用内插法通过校准曲线对片剂中的孟鲁司特钠和盐酸班布特罗进行定量测定。在第二种方法中，采用多组分分析模式，在95%甲醇中于283.6 nm（孟鲁司特的最大吸收波长）和211.8 nm（为盐酸班布特罗选择的工作波长）两个波长处测量吸光度。这些方法按照ICH指南进行了统计学验证。回收率研究证实了所提出方法的准确性。
