Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR THE ESTIMATION OF CEFTAROLINE FOSAMIL IN BULK AND PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Faraat Ali*, Dr. G. N. Singh, Dr. P. L. Sahu, Dr. Robin Kumar, Ms. Manisha Trivedi

ABSTRACT

A simple, sensitive, accurate and precise reverse phase gradient high performance liquid chromatographic (RP-HPLC) method has been developed for the estimation of Ceftaroline Fosamil in bulk and pharmaceutical dosage forms. Analytical method was developed by using Waters X-Bridge Shield C-18 (4.6×150 mm, 5μm) column; mobile phase consisting of ACN and ammonium dihydrogen phosphate buffer at pH 9.0; the flow rate of 1.0 ml/min and detection wavelength 214nm and eluted at 4.334 min. The linearity ranges were 25 to 125ppm for Ceftaroline fosamil. According to ICH guidelines, method was validated for various parameters like linearity, precision, accuracy, LOD, LOQ and robustness. Validated method was applied to the commercially available pharmaceutical dosage forms and obtained the desired result. So the method can be successfully applied for routine analysis.

Keywords: Ceftaroline fosamil, Acetonitrile, HPLC, Validation, Development.