Abstract

STABILITY INDICATING RP-UPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF ANTIALLERGIC DRUGS IN BULK & TABLET DOSAGE FORM

*Anamika Kakad

Abstract

A rapid, precise, and stability-indicating RP-UPLC method was developed and validated for the simultaneous estimation of selected anti-allergic drugs in bulk and tablet dosage forms. Separation was achieved using a suitable reverse-phase column with an optimized mobile phase composition to ensure sharp peak resolution and reduced run time. The method was validated in accordance with ICH guidelines, evaluating parameters such as linearity, accuracy, precision, robustness, specificity, and sensitivity. Forced degradation studies under acidic, alkaline, oxidative, thermal, and photolytic conditions confirmed that the method can effectively distinguish the active pharmaceutical ingredients from their degradation products. The developed RP-UPLC method demonstrated high reproducibility and reliability for routine quality control analysis of anti-allergic formulations. Its sensitivity and stability-indicating capability make it suitable for application in both pharmaceutical research and industrial environments.

Keywords: RP-UPLC, method development, method validation, anti-allergic drugs, stability-indicating method, simultaneous estimation, forced degradation studies, ICH guidelines, bulk drug, tablet dosage form.