Abstract

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR SIMULTANEOUS ESTIMATION OF ISONIAZID AND CYCLOSERINE BY RP-HPLC WITH FORCED DEGRADATION STUDIES

Girish N.* and Chandrashekar Javali

ABSTRACT

A new, selective, accurate, precise and reproducible High-Performance Liquid Chromatographic (HPLC) method was developed and validated for the analysis of Isoniazid and Cycloserine. Chromatographic separation achieved isocratically on a C18 column (Zodiac C18 column (250×4.6mm, 5μm) and Potassium Dihydrogen ortho Phosphate buffer pH 7: Methanol (80:20v/v) at flow rate at 234nm. The retention time of Isoniazid and Cycloserine was found to be 3.943 min and 5.569 min respectively. The mean values of the correlation coefficient were 0.999 for Isoniazid and 0.999 for Cycloserine. The method was validated to comply with international conference on harmonization (ICH) requirements with various parameters. The forced degradation studies were performed and % degradation was calculated and reported. Hence the proposed method can be used for the routine analysis of Isoniazid and Cycloserine in bulk and tablet dosage forms.

Keywords: Isoniazid, Cycloserine, RP-HPLC, Simultaneous estimation, ICH guidelines, Forced degradation studies.