Abstract

STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF METRONIDAZOLE AND RIFAXIMIN IN TABLET DOSAGE FORM

V. Mounika*, Sidda Vyshnavi, Nagaraju Pappula and G. Indira Priyadarshini

ABSTRACT

A new, sensitive, and rapid Stability indicating RP-HPLC method for estimation of metronidazole and rifaximin in tablet dosage form. The work was carried out by using YMC ODS column (150×4.6mm, particle size 3μ) and PDA detector at 282nm. The mobile phase containing Ammonium acetate Buffer: acetonitrile (40:60/v/v) pumped into a column at a flow rate 0.7mL/min. In accordance with ICH guidelines the method was validated. The linearity was found to be 2-10 μg/mL for Metronidazole and 1-5 μg/mL for Rifaximin respectively. The method was accurate with % recovery of 100.44%, and 100.62% for Metronidazole and Rifaximin respectively. The percentage relative standard deviation was NMT 2.0, indicating that it was precise and robust. All the results of validations parameters were within acceptable criteria according to ICH guidelines. Metronidazole and rifaximin was subjected to the stress conditions of acid, base, oxidative, thermal, and photolytic degradation. The extent ofdegradation was accomplished within the acceptable limits i.e., 5-20%. Well-resolved degradation products from the primary compounds proving the stability- indicating method.

Keywords: Metronidazole, Rifaximin, RP-HPLC, Degradation.