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首页> 外文期刊>International Journal of Pharmaceutical Sciences and Research >METHOD DEVELOPMENT AND VALIDATION OF TULOBUTEROL IN API AND ITS PHARMACEUTICAL DOSAGE FORMS BY UV SPECTROPHOTOMETRY
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METHOD DEVELOPMENT AND VALIDATION OF TULOBUTEROL IN API AND ITS PHARMACEUTICAL DOSAGE FORMS BY UV SPECTROPHOTOMETRY

机译:紫外分光光度法测定API中甲苯酚及其药物剂量形式的方法开发与验证

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摘要

A simple, accurate, sensitive and reproducible UV spectrophotometric method has been developed for the determination of Tulobuterol (TLB) in bulk and also in its pharmaceutical dosage formulations. The proposed method showed absorbance maxima at 212 nm. Beer’s law is obeyed over a concentration range of 25-125μg/mL. The respective linear regression equation being Y =0.009x +0.014 for TLB. Results of analysis for the method established, was validated statistically and also by recovery studies. The apparent molar absorptivity and Sandell’s Sensitivity values are 0.43×104 Lmol-1cm-1 and 0.0371 μgcm-2 respectively. The assay and recovery studies were found to be 99.16% and coefficient correlation(r) was found to be 0.999. The different experimental parameters effecting the development and stability were studied carefully and optimized. No interference was observed in the presence of common pharmaceutical excipients. The validity of the methods was tested by analyzing the drug in its pharmaceutical preparations. Good recoveries were also obtained. The developed method employed was successful for the determination of TLB in various pharmaceutical preparations.
机译:已经开发了一种简单,准确,灵敏且可重现的紫外分光光度法,用于测定散装中的妥洛特罗(TLB)及其药物剂型。所提出的方法在212 nm处显示最大吸光度。在25-125μg/ mL的浓度范围内遵守啤酒法则。对于TLB,各自的线性回归方程为Y = 0.009x +0.014。所建立方法的分析结果在统计学上以及通过回收率研究得到了验证。表观摩尔吸收率和Sandell灵敏度值为0.43×10 4 L mol-1 cm -1 和0.0371μgcm -2 < / sup>。测定和回收率研究的结果为99.16%,系数的相关性为0.999。仔细研究和优化了影响开发和稳定性的不同实验参数。在普通药物赋形剂的存在下未观察到干扰。通过分析药物制剂中的药物来测试方法的有效性。还获得了良好的回收率。所采用的开发方法成功地测定了各种药物制剂中的TLB。

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