eAn effective and stability-indicating method development and optimization utilizing the Box-Behnken Design for the simultaneous determination of Acetaminophen, Caffeine, and Aspirin in Tablets Formulation.

Analytical techniques must be sensitive, specific, and accurate in order to assess the active pharmaceutical ingredients in pharmaceutical dosage forms. The Quality by Design (QbD) application has proven to be a practical method for magnifying HPLC operations. This article discusses the successfully developed QbD-based stability-indicative LC method for evaluating acetaminophen, caffeine, and aspirin in tablet dosage form. To achieve the necessary chromatographic separation, milli-Q water, methanol, and glacial acetic acid were employed in the following ratios: 63:35:2 (v/v/v) for mobile phase-A and 18:80:2 (v/v/v) for mobile phase-B, respectively. The flow rate, column temperature, and detecting wavelength were 1.0 mL min -1 , 40° C, and 275 nm, respectively, with Inert sustain C18, (150 × 4.6mm), 3 μm analytical column. Linearity between 10.0 and 150.0 μgmL -1 of aspirin and acetaminophen and 2.6 to 39.0 μg mL -1 of caffeine. The accuracy findings were more than 97%, and the correlation coefficient for all three components was found to be greater than 0.999. The validated HPLC methodology yielded reliable and accurate results. Aspirin was shown to be very vulnerable to both acid and alkaline hydrolysis in the forced degradation study. The described method is capable of separating the degradants produced during stress testing and is regarded as stability-indicating. The proposed method can be used for a wider range of other formulations with an appropriate diluent selection and sample preparation procedure optimization.