DEVELOPMENT AND VALIDATION OF NOVEL RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GABAPENTIN AND AMITRIPTYLINE HYDROCHLORIDE IN BULK AND PHARMACEUTICAL DOSAGE FORMS
Keywords:Gabapentin, Amitriptyline hydrochloride, RP-HPLC, Analysis, Validation, ICH
Objective: To develop a novel, accurate, precise and linear reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous quantitative estimation of gabapentin and amitriptyline hydrochloride in gabantip-at tablet and validate as per international conference on harmonization (ICH) guidelines and to perform the force degradation studies using the developed method.
Methods: In the present work, good chromatographic separation was achieved isocratically using a shim-pack HPLC C18 column (4.6 x 250 mm, 5Î¼m) and mobile phase consisting of 0.05 M potassium dihydrogen orthophosphate pH 2.1 adjusted with orthophosphoric acid and acetonitrile in the ratio (55:45), at flow rate 1 ml/min and column temperature (25 Â°C). The effluents obtained were monitored at 221 nm with the UV-visible detector.
Results: The retention time of gabapentin and amitriptyline hydrochloride was found to be 1.959 min and 4.221 min respectively. The linearity of gabapentin was found in the range of 720-1680 ppm and that for amitriptyline hydrochloride was found to be 24-56 ppm. The correlation coefficient for gabapentin and amitriptyline hydrochloride were 0.999 and 0.9963 respectively. The high recovery values (98%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveals that the method is precise.
Conclusion: The developed method is novel, simple, precise, rapid, accurate and reproducible for simultaneous estimation of gabapentin and amitriptyline hydrochloride tablet dosage form. Hence the proposed method may find practical applications as a quality-control tool in the simultaneous analysis of the two drugs in combined dosage forms in quality-control laboratories.
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