ESTIMATION OF CEFEPIME HYDROCHLORIDE IN INJECTABLE DOSAGE FORM BY DIFFERENCE SPECTROPHOTOMETRY

C. A. Patel
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引用次数: 1

Abstract

Cefepime is used as beta- lactam antibiotic. In present study, a simple, rapid, accurate, and economical differencespectrophotometric method has been developed for the estimation of cefepime hydrochloride from pharmaceutical formulation. The developed method was statistically validated in accordance with ICH guideline on the basis of various parameters like linearity, accuracy, precision, sensitivity,and repeatability . The drug follows linearity in the concentration range 30-80 ?g/ml with a correlation coefficient value of 0.997 at ?max of 268.80 nm. The accuracy of the method was checked by recovery experiment performed at three different levels. The % recovery was found to be in the range of 99.30 to 100.25 %.The precision of the method was studied as an intraday; interday variations, and repeatability. The % RSD value < 2 indicates that the method is precise, reproducible and accurate. The proposed method was then successfully applied to pharmaceutical formulation. Amount of drug estimated was found between 99.7%, which was in good agreement with the label claim. Excipients used in injection did not interfere in the estimation of cefepime by developed method. The proposed method can be successfully employed in the routine analysis of drug in pharmaceutical dosage forms.
差示分光光度法测定注射剂型盐酸头孢吡肟的含量
头孢吡肟被用作-内酰胺类抗生素。本研究建立了一种简便、快速、准确、经济的盐酸头孢吡肟含量测定方法。根据ICH指南对所建立的方法进行了线性度、准确度、精密度、灵敏度、重复性等参数的统计验证。在30 ~ 80g /ml浓度范围内呈线性关系,相关系数为0.997,最大值为268.80 nm。通过三个不同水平的回收率实验,验证了该方法的准确性。回收率在99.30% ~ 100.25%之间。以日为单位研究了该方法的精度;日间变化和可重复性。% RSD值< 2表明该方法精密度高,重现性好,准确度高。该方法成功地应用于药物制剂。估计的药物量在99.7%之间,这与标签声明很好地一致。注射用辅料对头孢吡肟的测定无干扰。该方法可成功地用于药物剂型的常规分析。
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