Abstract
DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF GABAPENTIN AND AMITRIPTYLINE HYDROCHLORIDE IN ITS PHARMACEUTICAL DOSAGE FORM

Vyomesh B. Patel*, Geeta V. Chaudhari, Priyanka Shah and Suleman S. Khoja

ABSTRACT

A reversed-phase liquid chromatographic method has been developed and validated for estimation of Gabapentin and Amitriptyline Hydrochloride in Pharmaceutical Dosage Form. RP-HPLC method, Column used was Water Symmetry250 x 4.6mm 5μ C18, with mobile phase containing 20 mM Ammonium Acetate (PH 6.0) : Acetonitrile (65:35) %v/v The flow rate (1.0 ml/min) and wavelength (272 nm). The retention time for Gabapentin and Amitriptyline Hydrochloride was found to be 2.793± 0.01 min. and 4.831± 0.01 min. respectively. Correlation co-efficient for Gabapentin and Amitriptyline hydrochloride was found to be 0.999. Assay result of marketed formulation was found to be in 99.5 % and 98.7% for Gabapentin and Amitriptyline Hydrochloride. The proposed method was validated with respect to ICH Guideline. Percentage recovery for Gabapentin and Amitriptyline hydrochloride was found to be 99.0 – 100.0%.Analysis proves that the developed method was can be successfully applied for the analysis of pharmaceutical formulations and can be used for routine analysis of drugs in Quality Control laboratories.

Keywords: Gabapentin, Amitriptyline Hydrochloride, RP-HPLC, analytical method development, Validation, ICH, Chromatography.


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