Abstract

DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING METHOD BY ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY FOR THE DETERMINATION OF VANCOMYCIN DRUG IN VANCOMYCIN INJECTION

A. Mallibabu*, C. Hazarathaiah Yadav and P. Janaki Pathi

Abstract

The Analytical Method Development and Validation of Vancomycin drug in Vancomycin Injection is particularly designed to intended purpose of Pharmaceutical Industries. A simple, precise, rapid and accurate reverse phase UPLC method was developed for the estimation of Vancomycin drug in Vancomycin Injection. Waters xterra RP18, 150mm x 3.9mm, 5μm with mobile phase consisting of monobasic ammonium phosphate buffer 0.05M and acetonitrile were mixed in the ratio 90:10 (v/v) respectively and degassed for about 10 minutes. Isocratic mode of chromatography technique was used. The flow rate was 0.7 mL/min and the eluents were monitored at 230 nm. The retention time of the Vancomycin peak is about 3.5 minutes. The detector response was linear in the concentration of 5.03 to 15.08 mcg/mL, Y-intercept is -49657 and slop is 754605.4. The percentage assay of Vancomycin was 100%. The method was validated by determining its accuracy, precision and linearity with inline of International Council on Harmonization guidelines, ICH Q2R1.

Keywords: Vancomycin Injection, Analytical Method by UPLC, Reverse Phase Chromatography, Stability Indicating, Isocratic mode of Chromatography Technique and Industrial Intended Purpose.