Two simple, rapid, sensitive and accurate spectrophotometric methods are described for the determination of Pregabalin (PRG) in bulk and pharmaceutical formulations. The methods are based on the reactions of the drug with bromocresol purple (BCP) and bromocresol green (BCG) in buffered hydrochloric acid solutions at pH 1.2 to give coloured ion-pair complexes extractable with chloroform. The coloured products are quantitated spectrophotometrically at 431 nm with BCP and 444.80 nm with BCG. Beer's law is obeyed in the concentration range 10-50 µg/ml with both reagents. Recovery studies gave satisfactory results indicating that none of common additives and excipients interfere the assay method. The proposed methods are found to be simple, accurate and reproducible that was successfully applied for the analysis of capsule formulations. The developed methods are easy to use, accurate and highly cost-effective for routine studies relative to HPLC and other techniques.
A simple, specific, quick, isocratic Reversed Phase High Performance Liquid Chromatographic method was developed and validated for the analysis of Pregabalin in bulk and 5-different pharmaceutical formulations, the separation was accomplished on a C18, 5μm Reverse Phase column (250 mm × 4.6 mm) using a methanol : water (95:5, v/v) mobile phase. The compound was eluted isocratically at a flow rate of 0.8 ml /min. The UV detector was set at 288 nm for the detection of Pregabalin (PRG). The method was linear over the range of 5-45 μg/ml and validated with respect to accuracy, precision, linearity, and specificity, limit of detection and limit of quantization. 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-different pharmaceutical formulations with good precision and accuracy.
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