Abstract

DEVELOPMENT AND VALIDATION OF UV SPECTROPHOTOMETRIC FOR DETERMINATION OF HYDROXYZINE PAMOATE BULK AND IN SUSPENSION FORM

T. Sudha*, M. Sathiya, C. Sathiyapriya, R. Sunitha, A. Vishali and J. Sujitha

ABSTRACT

The main objective was to develop and validate the UV-spectrophotometric method for the determination of Hydroxyzine pamoate bulk and in suspension formulation as per ICH guidelines. A simple, rapid, accurate and economical UV-spectrophotometric method has been developed for the estimation of Hydroxyzine pamoate bulk and in suspension formulation. The λmax of Hydroxyzine pamoate in methanol: buffer (50:50) was found to be 235 nm. The drug follows linearity in the concentration range 1–9 μg/ml with a correlation coefficient value of 0.999. The proposed method was applied to pharmaceutical formulation and percentage amount of drug estimated was 100.73%. It was found to be in good agreement with the label claim. The accuracy of the method was checked by recovery experiment performed at three different levels, i.e., 50%, 75% and 100%. The percentage recovery was found to be in the range from 99.2 to 101.6%. The percentage RSD value was found to be 1.3219. The low percentage RSD value indicated there was no interference due to excipients used in formulation. The proposed UV spectroscopy method can be effectively applied for the routine analysis of Hydroxyzine pamoate in the suspension formulation.

Keywords: Hydroxyzine pamoate, UV Spectrophotometric method, Validation, ICH guidelines, IR Spectrum.