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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 was
developed for the quantification of Z-isomer impurity and intermediate
in 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 developed
for assay and gradient method for related substance. 300 nm
wavelength selected. During method validation of related substance
detection and quantification limit was achieved on 0.1 ppm and 0.2
ppm level for known impurities and active substance. During method
validation of both methods all parameters are within acceptance
criteria, hence comparative study was performed between assay and related substance method
of entacapone API. This study assures us correctness between reporting values and presence
of amount of total impurities. In our study we observed same amount of difference between
total impurities under related substance method and assay method.

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


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