New Method Development for Hydroxyzine Determination: Application in Stability Studies, Pharmaceutical Formulations, and Humane Serum

Abstract

This article pertains to development and validation of a low cost, fast, sensitive, and accurate RP-HPLC method for quantitative analysis of HZ. A Hibar μBondapak C₁₈ column as the stationary phase and acetonitrile:methanol:buffer (500:200:300) as the mobile phase were used to accomplish the separation, when drawn at a flow rate of 1.0 mL/min, with 235 nm as monitoring wavelength. Linearity was established by studying the drug over the concentration range of 10–10000 ng mL⁻¹, correlation coefficient of r = 0.9993, drug recovery (97 to 102%), and high reproducibility in serum samples (less than 2.5% RSD) displayed excellent linearity, accuracy, and precision. Force degradation studies of the drug under various stress conditions (acid, base, oxidation, photo, and thermal) proved the stability indicating power of the method. Substantial method validation study was carried out inline with ICH guidelines and was applied successfully to quantify the amount of HZ in bulk, pharmaceutical formulations, and blood serum samples.

Keywords:

• Blood serum
• dosage formulation
• HPLC UV
• hydroxyzine
• preservatives
• stability studies

Acknowledgments

The authors declare that they do not have any conflict of interests regarding the publication of this paper.