Abstract

RP-HPLC ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS OF OLAZAPINE AND SAMIDORPHAN IN BULK AND TABLET DOSAGE FORM

Sagili Varalaxmi*

ABSTRACT

AIM: The main aim of the present study is to develop an accurate, precise, sensitive, selective, reproducible and rapid analytical technique for simultaneous estimation of Olanzapine– Samidorphan in bulk and pharmaceutical dosage form. The proposed method will be validated in accordance with regulatory guidelines to ensure its reliability and robustness for routine quality control analysis. Furthermore, the method aims to demonstrate good linearity, specificity, and stability-indicating capability under various stress conditions. This study also seeks to provide a cost-effective and time-efficient approach suitable for pharmaceutical industries and research laboratories.

Keywords: Samidorphan, Olanzapine, RP-HPLC, Method Development, Validation.