Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GABAPENTIN AND NORTRIPTYLINE HYDROCHLORIDE IN BULK AND COMBINED DOSAGE FORM

Srihari Konda* and Shanta Kumari Katakam

Abstract

A new Simple, Precise, Fast and Accurate RP-HPLC Method has been developed and validated for simultaneous estimation of Gabapentin (GABAP) and Nortriptyline Hydrochloride (NTH) in bulk and combined dosage form. The method was carried out on the chromatographic separation was achieved by isocratic elution technique on (reverse phase) Luna C18 column (250 mm x 4.6 mm ID, Particle size 5m), using mobile phase composition of Water: acetonitrile in the ratio of 60:40 v/v with a flow rate 1.2ml/min. Quantization was achieved with PDA detector 255nm based on peak area. The retention time of GABAP and NTH were found to be 3.457min and 4.728min respectively. The GABAP and NTH followed linearity in the concentration range of 50-500μg/ml and 1-12.5μg/ml respectively with r²=0.999 for both GABAP and NTH .The amount of both drugs estimated by the proposed method was found to be in good agreement with labelled claim. The developed method was validated for precision, accuracy, sensitivity, robustness and ruggedness. The developed method can be used for routine analysis of titled drugs in combined dosage form.

Keywords: Gabapentin and Nortriptyline hydrochloride, RP-HPLC validation C18 Column ICH Guidelines.