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Quantitation of pregabalin by HPLC-UV method using ninhydrin derivatization: development and validation

Mutalabisin, Fathiy and Helaluddin, Abul Bashar Mohammed and Sengupta, Pinaki and Mohamed, Farahidah and Chatterjee, Bappaditya (2021) Quantitation of pregabalin by HPLC-UV method using ninhydrin derivatization: development and validation. Current Pharmaceutical Analysis, 17 (1). pp. 165-171. ISSN 1573-4129 E-ISSN 1875-676X

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Abstract

Introduction: A simple and reliable high performance liquid chromatographic method has been developed for the quantitative determination of pregabalin in bulk and dosage form. Pregabalin, a γ amino butyric acid analogue, has negligible sensitivity to UV or fluorescence detection. Hence, it has been derivatized by ninhydrin to form a chromophoric complex that could be quantified by UV detec-tion. Materials and Methods: The concentration of ninhydrin was set to 5 mg/ml and a phosphate buffer solution (pH 7.4) was used as a solvent for the reaction. The resultant complex was separated by HPLC and detected by a 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. © 2020 Bentham Science Publishers.

Item Type: Article (Journal)
Additional Information: 4478/88064
Uncontrolled Keywords: Pregabalin, ninhydrin, precolumn derivatization, HPLC, UV detection, analytical method development, analytical method validation.
Subjects: R Medicine > RS Pharmacy and materia medica > RS192 Materia Medica-Pharmaceutical Technology
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button): Kulliyyah of Pharmacy
Depositing User: Dr. A. B. M. Helal Uddin
Date Deposited: 27 Jan 2021 13:07
Last Modified: 27 Jan 2021 13:08
URI: http://irep.iium.edu.my/id/eprint/88064

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