Advanced International Journal for Research

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Influence of Organic Acids Excipients: A Comparative Analysis Study of Aspirin in Analgesic Drug Formulation

Author(s) Mr. ANTHONY ODUOR OCHIENG
Country Tanzania
Abstract Aspirin (acetylsalicylic acid, ASA) remains one of the most widely used analgesic and anti-inflammatory agents, making accurate and reliable quantification in pharmaceutical formulations a critical quality control requirement. Classical titrimetric assays using sodium hydroxide exploit the carboxylic acid functionality of ASA, but their lack of selectivity leads to overestimation in multicomponent formulations where organo-acidic excipients also consume the base. In this study, six commercial aspirin tablet formulations from established manufacturers were comparatively analyzed using Titrimetric, UV–Vis spectrophotometry with multivariate calibration, and hyphenated chromatographic methods (HPLC). Results indicates that titrimetric assays required complex stoichiometric corrections, manipulations and produced inconsistent values in formulations containing interfering acidic excipients. Spectrophotometric methods offered rapid screening but frequently yielded results at or below the lower pharmacopeia specification limits, reflecting limited robustness in complex matrices. By contrast, the chromatographic techniques provided superior resolution, precision, and accuracy, consistently yielding results within United States Pharmacopeia (USP) and British Pharmacopoeia (BP) limits. The findings also highlight the trade-off between simplicity and specificity across analytical approaches, underscoring the importance of chromatographic confirmation for regulatory compliance and stability testing, while recognizing the continued relevance of low-cost methods for routine screening in resource-limited settings.
Keywords Aspirin; Quality control; Titrimetric; UV–Vis spectrophotometry; HPLC; Pharmacopeias limits; Organic Acids Excipients
Field Chemistry > Pharmacy
Published In Volume 6, Issue 5, September-October 2025
Published On 2025-10-13
DOI https://doi.org/10.63363/aijfr.2025.v06i05.1490
Short DOI https://doi.org/g97nxv
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