Abstract

DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR PAMABROM IN BULK & PHARMACEUTICAL DOSAGE FORM

P. B. Jadhav*, S. G. Bhokare, M. N. Madibone and A. A. Kirdak

ABSTRACT

An accurate, Precise, Simple and Economical High Performance Liquid Chromatographic method for the estimation of Pamabrom in bulk form has been developed. The method so developed is Reverse Phase High Performance Liquid Chromatographic method using Primesil C18 column (Length: 250nm, Diameter: 4.6nm, Particle size: 5μ) with a simple methanol and Water (0.05% OPA) mixed in a proportion of 80:20 v/v as mobile phase. The retention time for Pamabrom was found to be 4.48 min. The linearity for the method was observed in a concentration range of 10-50μg/mL with the correlation coefficient of 0.999. The method so developed was validated in compliance with the regulatory guidelines by using well developed Analytical method validation tool which comprises with the analytical method validation parameters like Linearity, Accuracy, Method precision, Specificity, System suitability, Robustness and Ruggedness. The results obtained were well within the acceptance criteria.

Keywords: Pamabrom, RP-HPLC, Method Development, Validation, UV.