Abstract

Rajinder Singh Gujral*, Sk Manirul Haque and Sanjeev Kumar

A simple isocratic reversed phase HPLC method was developed and validated for the analysis of pregabalin in bulk, pharmaceutical formulations and human urine samples, the separation was accomplished on a C18 5 µm ODS hypersil column (250 mm × 4.6 mm) using a methanol acetonitrile - 0.02 M di - potassium hydrogen orthophosphate (K 2HPO 4) (pH - 7.00) (3: 1: 16, v/v/v) mobile phase. The compound eluted isocratically at a flow rate of 1.0 ml /min. The UV detector was set at 210 nm for the detection of pregabalin. The method was linear over the range of 0.75 - 6.00 µg/ml. The method was validated with respect to accuracy, precision, linearity, ruggedness, limit of detection and limit of quantitation. Robustness testing was also conducted to evaluate the effect of minor changes to the chromatographic system and to establish appropriate system suitability parameters. This method was used successfully for the quality assessment of 5 pregabalin drug products and human urine samples with good precision and accuracy.