Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ASSAY FOR FOSINOPRIL TABLETS BY HPTLC AND UV SPECTROSCOPY

Megha Gour* and Archana Tiwari

ABSTRACT

The aim was to develop and validate a simple, precise, rapid, less expensive, linear and accurate methods HPTLC and UV spectroscopy for the estimation of fosinopril sodium in tablet formulations. In HPTLC during the stage of method development different mobile phase were tried and mobile phase comprising of ethyl chloroform: methanol: toluene in the proportion of 1.5: 3: 3.5 v/v/v for fosinopril sodium, were found to be better and produced the Rf value of 0.72 for fosinopril sodium. In case of UV- spectroscopic method solubility is the important parameter. Solubility parameter was studied and methanol was selected as the solvent, since it gave a maximum absorbance and a good spectral pattern when compared with other solvents. The method was validated as per ICH-Q2R1 guidelines. The HPTLC method observed linearity of drug was determined by calibration curve and the linearity based on the area observed in the range of 0.1 – 0.5μg/ ml. The regression coefficient value for fosinopril sodium is 0.999. Interday precision of the drugs was studied. In case of UV-spectroscopic method the linearity was found to be in the range of 1 -5μg/ml at the maximum absorbance of 242nm.The solution was scanned and measured at 242 nm. The correlation co-efficient value was found to be 0.998. The proposed HPTLC and UV spectroscopic method for the quantification of fosinopril sodium in tablet formulation is simple, accurate, and rapid and can be employed for the repeatability analysis. This method can be applied for the substances which obey Beer’s law.

Keywords: Fosinopril sodium, HPTLC, UV, Methanol, Method Development, Validation.