Method Development and Validation of UV-Spectrophotometric Estimation of Hydroxychloroquine Sulphate in Bulk and Pharmaceutical Dosage Form

Abstract

Aims: The devised method for estimating hydroxychloroquine sulphate in bulk and pharmaceutical dose forms (tablets) is the subject of this work. The method can therefore be applied to regular quantitative analysis and stability. The following describes the planned work's goal and scope: • To create an appropriate spectrophotometric method for tablet-based hydroxychloroquine sulphate estimation. • Carry out the method's validation. Methodology: These techniques include the area under curve (AUC) method-I and the A1% solution method based on absorbance measurement, or method-II, both of which are chosen at wavelengths of 329.4 nm using a UV-visible spectrophotometer with a 1 cm matched quartz cell and 0.01N acetic acid with water as a solvent. Results: Plots of the hydroxychloroquine sulphate absorption spectra in 0.01N acetic acid were made. 329.4 nm was found to be the average maximum. With correlation coefficients of 0.9992 and 0.999 (r2>0.999) for AUC and 1%, respectively, and a linear connection between the absorbance and drug concentration in concentration ranges of 5-35 g/mL, it is clear that the method is linear. The percentage of medication calculated by various methods was close to 100.12, and 99.41% of the results were consistent with the label claim of the commercially available tablet formulation. As per ICH requirements, the validation parameter research was completed. Conclusion: The described UV methods offer good accuracy and precision with reduced limits of detection and quantification. They are straightforward, trustworthy, and highly selective. These disclosed methods are ideal for routine quantitative analysis in pharmaceutical dosage forms due to the decreased time required for analysis of hydroxychloroquine sulphate. The time-saving, low-cost alternative to the expensive high-performance liquid chromatographic technology is the applied spectrophotometric approaches.