Abstract

ADVANCES IN STABILITY-INDICATING BY CHROMATOGRAPHIC METHODS FOR HYDROCHLOROTHIAZIDE AND METOPROLOL SUCCINATE ENSURING QUALITY, SAFETY, AND EFFICACY IN FIXED-DOSE COMBINATIONS

Aryan Ji Verma, Neha Nahid, Rohit Kumar and Tanya Sharma*

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Abstract

Here, we focused on the combination of hydrochlorothiazide and metoprolol succinate in fixed-dose formulations has gained significant attention in the treatment of hypertension and cardiovascular diseases. Ensuring the quality, safety, and efficacy of these formulations necessitates the development of robust stability-indicating chromatographic methods. This review explores recent advances in high-performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), and other chromatographic techniques used for the stability analysis of hydrochlorothiazide and metoprolol succinate. Various analytical approaches, method validation parameters, and regulatory perspectives are discussed to highlight best practices for pharmaceutical quality control.

Keywords: RP-HPLC, Hydrochlorothiazide (HCT), Metoprolol Succinate (MET), Quality, Fixed-Dose Combination (FDC), Design (QbD), UPLC.