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分光光度法测定头孢呋辛酯原料药及其片剂剂型中的含量。

Spectrophotometeric Determination of Cefuroxime Axetil from bulk and in its tablet dosage form.

作者信息

Shinde M V, Pishawikar S A, More H N

机构信息

Department of Pharmaceutical Chemistry, Bharati Vidyapeeth College of Pharmacy and Research Center, Near Chitranagari, Kolhapur-416 013, India.

出版信息

Indian J Pharm Sci. 2008 Mar-Apr;70(2):249-51. doi: 10.4103/0250-474X.41468.

Abstract

A simple rapid spectrophotometric method has been developed for estimation of cefuroxime axetil from bulk drug and tablet dosage form by using 1-nitroso-2-napthol and sodium hydroxide. The method is based on the formation of yellow-orange coloured complex of drug with 1-nitroso-2-napthol having absorbance maxima at 424 nm. The Beer's law is obeyed in the concentration range of 10-50 mug/ml of the drug but more precisely it obeys in the range of 10- 30 mug/ml. The slope and intercept values are 0.0101 and 0.0838, respectively. Results of analysis of this method were validated statistically and by recovery studies. The method is applied to the marketed tablet formulation. Result of analysis of tablet formulation given as percentage of label claim +/-standard deviation is 99.17+/-1.57. The precision and accuracy was examined by performing recovery studies and was found to be 99.50+/-1.82. Sandell's correlation coefficient is calculated as 0.4434. The developed method is simple, sensitive and reproducible and can be used for routine analysis of cefuroxime axetil from bulk and tablet dosage form.

摘要

已开发出一种简单快速的分光光度法,用于通过使用1-亚硝基-2-萘酚和氢氧化钠从原料药和片剂剂型中估算头孢呋辛酯。该方法基于药物与1-亚硝基-2-萘酚形成橙黄色络合物,其在424nm处有最大吸收。在药物浓度为10-50μg/ml范围内符合比尔定律,但更精确地说,在10-30μg/ml范围内符合。斜率和截距值分别为0.0101和0.0838。该方法的分析结果通过统计学和回收率研究进行了验证。该方法应用于市售片剂剂型。片剂剂型分析结果以标签标示量的百分比±标准差表示为99.17±1.57。通过进行回收率研究检查了精密度和准确度,结果为99.50±1.82。计算出桑德尔相关系数为0.4434。所开发的方法简单、灵敏且可重现,可用于从原料药和片剂剂型中对头孢呋辛酯进行常规分析。

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本文引用的文献

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