DEVELOPMENT AND VERIFICATION OF UV SPECTROPHOTOMETRIC TECHNIQUE FOR DETERMINING N-ACETYLCYSTEINE IN TABLET FORMULATIONS
DOI:
https://doi.org/10.22159/ijpps.2024v16i10.51004Keywords:
N-acetylcysteine, UV-Visiblespectroscopy, ICH guideline, Dosage form, ValidationAbstract
Objective: This study aimed to determine the concentration of N-Acetyl Cysteine (NAC) in tablet formulations using UV-Visiblespectroscopy.
Methods: A precise and accurate UV spectrophotometric method was developed for determining N-acetylcysteine in tablets, using 0.1N NaOH as a diluent. The drug's purity was assessed using UV-visible spectrophotometry, which validated linearity, accuracy, precision, specificity, limit of detection, and quantification.
Results: The calibration curve had a high correlation coefficient (r2 = 0.9992) and maximum absorbance at 235 nm. There was no interference in dosage. The results showed 100.17% mean % recovery and 100.27% tablet assay, with a precision of 0.60% and 0.57%, respectively. The method was robust and rugged.
Conclusion: The method was evaluated using statistical parameters, including precision, accuracy, linearity, recovery, and robustness. The results showed no significant differences compared to other methods. The method can be used to analyse pharmaceutical formulations quickly, and no significant differences in mean values and standard deviations were found.
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References
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