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STABLE LIQUID CHROMATOGRAPHY METHOD FOR THE RESOLUTION AND QUANTIFICATION OF RELATED IMPURITIES OF FOSAMPRENAVIR IN BULK AND PHARMACEUTICAL FORMULATIONS

Singh G. V. S.a*, Reddy D. R. S.b and Divakar T. E.c

a Department of Chemistry, SRR & CVR Government Degree College (A), Vijayawada - 520 004, Andhra Pradesh, India

b Department of Chemistry, Krishna University, Machilipatnam - 521 001, Andhra Pradesh, India

c Department of Chemistry, Noble College (A), Machilipatnam - 521 001, Andhra Pradesh, India

* For Correspondence E-mail: vijayssgaddala@gmail.com


ABSTRACT

Highly resolved and validated Liquid Chromatography method was developed for the separation and quantification of fosamprenavir and its related impurity 2 and 5 in bulk and pharmaceutical formulations. Separation of fosamprenavir and its impurities was achieved on prontosil ODS C18 column using mobile phase composition of methanol and 0.1 m sodium acetate in the ratio of 40:60 (v/v) at pH 5.9 as mobile phase at a flow rate of 0.9 mL/min in isocratic condition. Uv detection of the eluents was monitored at a wavelength of 246nm. In these conditions, well resolved peaks were observed at a retention time of 8.67, 5.73 and 4.00 min for fosamprenavir, Impurity 2 and 5, respectively. Calibration curve was plotted in the concentration range of 75-450 µg/mL for fosamprenavir and 1-6 µg/mL for impurity 2 and 5. Forced degradation study confirms that the method can separate the known and unknown impurities of fosamprenavir and the % degradation was found to be very less in all the stress conditions. Hence the method is suitable for the identification and quantification of impurities 2 and 5 along with fosamprenavir in bulk drug and formulations.

Year 2019 | Volume No. 56 | Issue No.09 | Page No. 37-42
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