METHOD DEVELOPMENT AND VALIDATION OF CEFEPIME BY USING RP-HPLC ALONG WITH ITS POTENCYAbstract
Cefepime is a broad – spectrum new parenteral cephalosporin used to treat moderate to severe nosocomial pneumonia, empirical treatment of febrile neutropenia and infections of the skin and urinary tract. In this present study a simple, accurate and precise reverse phase high performance liquid chromatographic method was developed and validated for analysis of cefepime powder for injectable solutions along with its potency by using microbiological bioassay by four different microorganisms. A YMC C 18 (4.6 × 150 mm, 5.0 mm) column was used for cefepime separation, using isocratic elution with acetonitrile: water (70:30, v/v) and UV detection at 235 nm. Microbiological assay (bioassay) was performed using the agar diffusion method. The validation performed yielded good results in terms of linearity, precision, accuracy, and robustness. The retention time obtained for cefepime was 1.77 min and % potency of the marketed dosage form was found to be 147.9%, 100%, 83.17% and 125.8% respectively.
S. J. Rani * and N. Mounika
Department of Pharmaceutical Analysis, Sri Padmavathi Mahila Visvavidyalayam, Tirupati, Andhra Pradesh, India.
14 September, 2017
21 March, 2018
13 May, 2018
01 June, 2018