Breaking barriers in pharmaceutical analysis: Streamlined UV spectrometric quantification and stability profiling of haloperidol and methylparaben in liquid formulations.

This study aims to quantify haloperidol and methylparaben in a liquid pharmaceutical formulation (2 mg/ml) using UV spectrometry and the simultaneous equations method. Additionally, we explored the stability of haloperidol under various stress conditions. The UV analysis revealed maximum absorption peaks at 248 nm for haloperidol and 256 nm for methylparaben, using a 1 % (v/v) lactic acid solution as the solvent. Method validation, conducted according to ICH guidelines, affirmed the method's reliability, showing excellent results in terms of linearity, precision, accuracy, and sensitivity. The method allows direct application to finished products, enabling simultaneous quantification without extractions. Its simplicity, speed, and cost-effectiveness make it ideal for routine controls in pharmaceutical industry haloperidol solution analyses. The method extends to monitoring forced degradation, indicating photolytic and hydrolytic degradation under acidic and basic conditions, while affirming thermal and oxidative stability. This proposed UV spectrometric method serves as a compelling alternative to pharmacopeia-recommended techniques, simplifying simultaneous determination of the active ingredient and preservative. This streamlines analysis, reducing time and costs. Additionally, it proves valuable in small industries lacking sophisticated instrumentation, offering insights into active ingredient behavior during forced degradation. Copyright © 2024 Elsevier Inc. All rights reserved.

Citation

Khadidja Djilali, Rachida Maachi, Zohra Ait Mesbah, Nourddine Nasrallah, Nabil Touzout, Hichem Tahraoui, Jie Zhang, Abdeltif Amrane. Breaking barriers in pharmaceutical analysis: Streamlined UV spectrometric quantification and stability profiling of haloperidol and methylparaben in liquid formulations. Analytical biochemistry. 2024 Dec;695:115632

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PMID: 39089362

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