Abstract

COMPARATIVE STUDY BETWEEN ASSAY AND RELATED SUBSTANCE METHOD IN ENTACAPONE API BY HPLC

Sachin D. Zade*, Dr. Shashikant Aswale, Dr. Sunanda S. Aswale and Padma S. There

Abstract

A linear and accurate Assay and related substance method wasdeveloped for the quantification of Z-isomer impurity and intermediatein entacapone API. Separation obtained on Phenomenox Kinetex C18,(100 x 4.6) mm, 2.6 micron column. Mobile phase contain 0.1%Orthrophosphoric acid in water: Methanol. Isocratic method developedfor assay and gradient method for related substance. 300 nmwavelength selected. During method validation of related substancedetection and quantification limit was achieved on 0.1 ppm and 0.2ppm level for known impurities and active substance. During methodvalidation of both methods all parameters are within acceptancecriteria, hence comparative study was performed between assay and related substance methodof entacapone API. This study assures us correctness between reporting values and presenceof amount of total impurities. In our study we observed same amount of difference betweentotal impurities under related substance method and assay method.

Keywords: HPLC, Assay, Related substance and Entacapone API.