DEVELOPMENT AND VALIDATION OF A FOLIN–CIOCALTEU-BASED SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF BISACODYL IN BULK PHARMACEUTICAL MATERIAL
DOI:
https://doi.org/10.69598/tbps.21.2.203-213Keywords:
bisacodyl, Folin–Ciocalteu reagent, colorimetric analysisAbstract
A simple colorimetric spectrophotometric method was developed and validated for the indirect quantification of bisacodyl (BIS) in bulk pharmaceutical material using the Folin–Ciocalteu (F–C) reagent. The method was based on hydrolysis of BIS to its phenolic derivative, bis-(p-hydroxyphenyl)-pyridyl-2-methane, followed by a F–C redox reaction to form a molybdenum–tungsten blue chromophore measurable at 740 nm. Experimental variables, including hydrolysis conditions, solvent composition, reagent ratios, and reaction time, were optimized to achieve clear solutions and reproducible color development. The method was validated in accordance with ICH Q2(R2) guidelines and demonstrated acceptable specificity, linearity over 8–24 µg/mL (R² = 0.9979), accuracy (99.1–101.4%), and precision (intra- and inter-day %RSD < 2%). The limits of detection and quantification were 0.91 and 2.77 µg/mL, respectively. The method was robust with respect to small variations in reaction time and measurement wavelength. Owing to its simplicity and minimal reagent consumption, the method is suitable for routine quality control analysis of BIS in bulk pharmaceutical material and offers a practical alternative to chromatographic methods.
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