Abstract

DULOXETINE HYDROCHLORIDE METHOD DEVELOPMENT USING OFFICIAL DISSOLUTION MEDIA

Ajit Chandrakant Jadhav *, Mene Harshad Rajendra, Wackhaure Sandesh Tanhji, Mahanvar Sachin Mahadev

ABSTRACT

Aim/background: A simple, rapid, precise and economical spectrophotometric method has been developed for the quantitative estimation of Duloxetine Hydrochloride in pharmaceutical formulation. Materials and Methods: The simple, precise, economical and rapid method was developed and validated for the estimation of Duloxetine Hydrochloride using pH 6.8 phosphate buffer as a solvent. The stock solution of Duloxetine Hydrochloride was prepared and subsequent suitable dilution was prepared in pH 6.8 phosphate buffer to obtained standard curve. The standard solution of Duloxetine Hydrochloride shows absorption maxima at 289 nm. Results: The drug obeyed beer lambert’s law in the concentration range of 10-50μg/ mL with regression 0.9998 at 289nm. The overall % recovery was found to be 100.674% which reflects that the method is free from interference of the impurities and other additives used in formulation. The low value of % RSD was indicative of accuracy and reproducibility of the method. The %RSD for interday and intraday precision was found to be 1.246 and 0.742, respectively which is <2% hence proved that method is precise. Conclusions: The results of analysis have been validated as per ICH guidelines. The developed method can be adopted in routine analysis of Duloxetine HCL in Capsule dosage form as well bulk dosage form.

Keywords: Duloxetine HCL, 6.8 phosphate Buffer, UV Spectrophotometry, method development, Validation, ICH guidelines,