NEW VALIDATED RP-HPLC METHOD FOR THE ESTIMATION OF COFENDYL IN PHARMACEUTICAL FORMULATION
V. D. N. Kumar Abbaraju* and Shaik Lakshman
ABSTRACT
A simple, selective, linear, precise and accurate RP-HPLC method was developed and validated for rapid assay of Methyl And Propyl Hydroxy Benzoate in Bulk and Pharmaceutical tablet formulation. Isocratic elution at a flow rate of 0.3ml/min was employed on symmetry Chromosil C18 5 μm (150 x 4.6 mm) or equivalent. A mixture of Methanol: Water in the ratio of 50:50/v/v was prepared and used as mobile phase. The UV detection wavelength was 254nm and 20 μl sample was injected. The run time is 10min and the flow rate was found to be 1.5 ml/min. The % R.S.D for methyl hydroxy benzoate and propyl hydroxy benzoate are 0.4 and 0.7 respectively. The LOD was found to be 15μg/ml and the LOQ was found to be 25μg/ml. The average Percentage recovery for methyl hydroxy benzoate was found to be 101.7% and for propyl hydroxy benzoate 102.9. The method was validated as per the ICH guidelines. Thus, the proposed HPLC method can be successfully applied for the routine quality control analysis of formulations. The method developed is simple and is better than the methods reported in the literature.
Keywords: Methyl and Propyl Hydroxy Benzoate, Rp- HPLC, UV detection, Recovery.
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