Development and validation of a chromatographic method for the estimation of rifampicin in bulk and pharmaceutical formulations Venkataramana N.V.1, Desai Nivedita R1, Sreenivasa S1, Chaluvaraju K. C.2, Kumar D. B. Aruna1,* 1Department of Studies and Research in Chemistry, Tumkur University, Tumakuru-572103, India 2Deptartment of Pharmaceutical Chemistry, Government College of Pharmacy, Bengaluru-560 027, India *Corresponding Author E-mail: nirmaldb@rediffmail.com
Online published on 2 March, 2017. Abstract In the present study arapid, simple, selective, linear, precise, accurate and robust reverse phase high performance liquid chromatography method was developed and validated for the qualitative and quantitative analysis of rifampicin in bulk and pharmaceutical formulations and their degradation studies such as acid, alkali and peroxide stressed were carried out. Gradient elution at a flow rate of 1.0 ml min−1 was employed using symmetry syncronis C18 (250 x 4.6 mm 5μm), column at a temperature of 40°C. The mobile phase used consisted of phosphate buffer (A) and acetonitrile (B) (100%) in the ratio of 50: 50 v/v. The chromatograms were recorded at a wavelength of 236 nm using array detector. Linearity was observed in the concentration range of 25–125 μg/ml. The retention time of rifampicin was found to be 5.2 min. The method was validated as per the international conference on harmonization (ICH) guidelines and the proposed method can be successfully applied for the estimation of rifampicin in pharmaceutical formulations. Top Keywords Chromatography, formulation, rifampicin, analysis, acetonitrile. Top |