FT-IR METHOD DEVELOPMENT AND VALIDATION FOR QUANTITATIVE ESTIMATION OF NORTRIPTYLINE AND PREGABALIN IN PHARMACEUTICAL FORMULATION

Jyoti D. Ghogare*, Pranita P. Panchal, Umesh T. Jadhao

ABSTRACT

A Simple, rapid and cost-effective Fourier Transformation Infrared Spectroscopic method has been developed and validated for the estimation of Nortriptyline and Pregabalin in pharmaceutical tablet formulation. The quantitative analysis of Nortriptyline and Pregabalin by using KBr as diluent for analysis purpose. FT-IR range 1653 cm-1 for Nortriptyline (>C=C<) and 1643 cm-1 for Pregabalin (-COOH) were selected. This method was developed and validated for various parameters according to ICH guidelines. Linearity range were found to be 2-12 % w/w and 15-90 % w/w for Nortriptyline and Pregabalin, respectively. The correlation coefficient (r2) were found to be 0.9957 for Nortriptyline and 0.997 for Pregabalin. Limit of Detection were found to be for Nortriptyline 2.0712 %w/w and 12.8513 %w/w for Pregabalin. Limit of Quantification for Nortriptyline and pregabalin were found to be 6.2763 %w/w and 38.9436 %w/w, respectively. In addition to force degradation studies were carried out by using various conditions like Thermal, Photolytic and Sunlight as per guidelines.

Keywords: FT-IR Spectroscopy, Nortriptyline, Pregabalin, Method validation, ICH guidelines.