Fathiy Mutalabisin, A. B. M. Helal Uddin, Pinaki Sengupta, Farahidah Mohamed and Bappaditya Chatterjee*
Introduction: A simple and reliable high performance liquid chromatographic method has been developed for quantitative determination of pregabalin in bulk and dosage form. Pregabalin, a γ amino butyric acid analogue has negligible sensitivity to UV or fluroscence detection. Hence, it has been derivetized by ninhydrin to form a chromophoric complex that could be quantified by UV detection.
Materials and Methods: The concentration of ninhydrin was set to 5 mg/ml and phosphate buffer solution (pH 7.4) was used as solvent for reaction. The resultant complex was separated by HPLC and detected by UV detector at 569nm wavelength.
Results: The developed method showed a linear response within 50 to 600 µg/mL of pregabalin. The method was accurate with mean recovery values within 100 ± 2%. The repeatability of the method was established by intra-day and inter-day precision study. Finally a commercial pregabalin capsule was assayed by the developed HPLC method including ninhydrin derivatization. The result of the mean assay was found to be 100.37 ±2.94 %.
Conclusion: This is the first time we are reporting pregabalin analysis using ninhydrin derivatization for HPLC analysis. Therefore, the developed method can be considered as a significant improvement in pregabalin quantitation and it can be easily applied for routine quality control tests of pregabalin.
Pregabalin, ninhydrin, precolumn derivatization, HPLC, UV detection, analytical method development, analytical method validation.
Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, National Institute of Pharmaceutical Education & Research (NIPER), Ahmedabad, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan, Kulliyyah of Pharmacy, International Islamic University Malaysia, Kuantan