DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF TRAMADOL HCL IN BULK DOSAGE FORM

Ravindra Bhimraj Laware*, Hajare Pranit Pandurang, Aher Mahendra Ratan

ABSTRACT

A simple and reproducible method was developed for Tramadol HCl by Reverse Phase High Performance Liquid Chromatography (RP-HPLC). Tramadol HCL was separated on Greece C18 (4.6ID x 250mm, Particle size: 5 micron, using ortho phosphoric acid buffer pH 3.0 at wavelength of 225 nm using UV detector. Isocratic elution of methanol and water was used as a mobile phase with various ratios and flow rates, eventually 80:20 v/v methanol and water was being set with the flow rate of 1mL/min. The statistical validation parameters such as linearity, accuracy, precision,LOD, LOQ, Robustness, system suitability were checked, further the limit of detection and limit of quantification of Tramadol HCL concentrations were found to be 55.55ng/mL and 168.33ng/mL.

Keywords: RP HPLC, Tramadol HCl, methanol, validation