Novel Eco-Friendly Stability Indicating Capillary Zone Electrophoresis Method for Determination of Aripiprazole in Tablet Dosage form: DoE Directed Optimization, Development and Method Validation

Author(s)

Fajardo, Frank Alonso Gavilano ; Tavares, Marina Franco Maggi ; Rashid, Anas ; Prado, Maria Segunda Aurora

• Document type: Journal article
• Source: Journal of Pharmaceutical Sciences; v. 111, n. 12, p. 12-pg., 2022-11-15.

Abstract

In this work, a novel environment-friendly stability indicating capillary zone electrophoresis (CZE) method has been developed and validated for assaying the aripiprazole (ARP) in tablet dosage form. The separation of ARP from its degradation products and internal standard was achieved using a fused silica capillary column (30.2 cm x 75 mm ID), a background electrolyte containing 6 mmol L-1 ammonium formate buffer (pH 3) with 5% methanol under a potential of 15 kV and detection at 214 nm. The stability indicating ability of the method was investigated by analyzing ARP after being subjected to acidic, alkaline, thermal, photolytic, and oxidative stress conditions, according to ICH guidelines. Design of experiments was used during forced degradation and method optimization. Oxidation was the main degradation pathway among those evaluated. The drug was separated from its oxidative degradation products in less than 4 min. CZE method was linear between 60 - 140 mg mL(-1), R-2 = 0.9980, precise (intra-day 0.88% and inter-day 1.30%). The average recovery was 100.93 +/- 0.77%. This is the first method in the literature for quantification of ARP in the presence of its related degradation products with high separation efficiency, low operation cost and minimum solvent consumption. This method could be helpful in the routine quality control analysis in the pharmaceu-tical industries with least harmful effect on the environment. CZE is considered an eco-friendly alternative of conventionally HPLC methods.(c) 2022 Published by Elsevier Inc. on behalf of American Pharmacists Association. (AU)

• FAPESP's process: 12/50595-8 - Application of electrophoretic and cromatographic methods for simultaneous determination of drugs used in the treatment of hypercholesterolemia
• Grantee: María Segunda Aurora Prado
• Support Opportunities: Regular Research Grants