Abstract

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF GABAPENTIN AND NORTRIPTYLINE HYDROCHLORIDE BY UHPLC IN ORAL SOLID DOSAGE FORMS

Dr. C. N. Nalini*, R. Vijayakumar and J. Premlal

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Abstract

A new simple, precise, fast and accurate UHPLC method has been developed and validated for simultaneous determination of gabapentin and nortriptyline hydrochloride in oral solid dosage forms. The method was carried out on the chromatographic separation achieved by C18; 3.9mm X 50 mm; 5 microns column, using mobile phase composition of buffer; methanol in the ratio of 300;700 ml, buffer; o.2% of triethylamine, adjusted the PH 4.5 with orthophosphoric acid with a flow rate of 0.5ml/min. Retention time of gabapentin was found 1.845 min & nortriptyline hydrochloride was found 3.345 min. %RSD of gabapentin was found 0.25% & nortriptyline hydrochloride was found 0.31%. Regression Equation of gabapentin Y = 0.0106 X – 0.105, R2 = 0.9993 & Nortriptyline hydrochloride is Y = 3.0378 X + 158.8271, R2 = 0.9998. The method was developed simple and economical because retention time were decreased and the run time was decreased, that can be adopted in regular quality control tests in industries.

Keywords: Gabapentin and Nortriptyline Hydrochloride, UHPLC Validation, C18 column ICH guidelines.