Abstract

QBD APPROACH TO RP-HPLC METHOD DEVELOPMENT & VALIDATION OF SOVATELTIDE IN PHARMACEUTICAL DOSAGE FORM.

S. Vaidehi*, Dr. M. Vishal and T. Devanshi

ABSTRACT

This study aimed to develop and validate a robust Reverse-Phase High-Performance Liquid Chromatography (RP-HPLC) method for quantifying a pharmaceutical compound using a Quality by Design (QbD) approach. Based on initial trials, a broader range of mobile phase compositions and flow rates was selected. Seventeen experimental runs were conducted, and the responses, including theoretical plates, retention time, and tailing factor, were analyzed. The optimal conditions identified were 0.1% TFA: Methanol (40:60 % v/v) as the mobile phase, with a flow rate of 1.0 mL/min. The stationary phase used was YMC C18 (150 mm x 4.6 mm x 3 µ) and estimation was done using 210 nm. Sovateltide had a retention time of 4.308 minutes. It was demonstrated to have linearity within 15-45 µg/mL with a correlation coefficient of 0.9994. The % accuracy was in the range of 99.8.-100.4, 0.11-0.93 % at three levels. The outcomes for the precision study were within the limits. The method approach is effectively suggested for the routine estimation of Sovateltide in injections.

Keywords: Sovateltide, RP-HPLC, Quality by Design, Method Validation, Central Composite Design, ICH Guidelines.