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Quantitation of Pregabalin by HPLC-UV Method using Ninhydrin derivatization: Development and Validation

Author(s):

Fathiy Mutalabisin, A. B. M. Helal Uddin, Pinaki Sengupta, Farahidah Mohamed and Bappaditya Chatterjee*  

Abstract:


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.

Keywords:

Pregabalin, ninhydrin, precolumn derivatization, HPLC, UV detection, analytical method development, analytical method validation.

Affiliation:

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



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