Comparison of Paracetamol Levels Between Generic Drugs and Brand Name Drugs on the Market Using the UV-Vis Spectrophotometer Method
DOI:
https://doi.org/10.54445/pharmademica.v6i1.188Keywords:
paracetamol, generic drug, branded drug, UV-Vis spectrophotometry, method validationAbstract
Paracetamol is an analgesic and antipyretic drug available in both generic and branded forms. This study is aimed to compare the paracetamol content of the two types of tablets using a validated UV-Vis spectrophotometry method. This experimental study employed six tablet samples, consisting of three of each generic products and branded products from different manufacturers, with each sample analysed three times (n = 3). The method validation included linearity testing, LOD, LOQ, accuracy, and precision, while the statistical analysis was conducted using Shapiro–Wilk, Levene, and Kruskal–Wallis tests. The results of the study indicated a correlation coefficient (R) of 0.999, an LOD of 1.618 mg/L, a LOQ of 5.395 mg/L, a % recovery of 103.314–106.542%, and a %RSD of less than 2%. The paracetamol content of all samples was within the range 91.523%–100.881%, thus meeting the requirements of the Indonesian Pharmacopoeia VI (90.0%–110.0%). The Kruskal–Wallis test indicated that there were significant differences in the concentrations of the six samples (p = 0.029). Therefore, the UV-Vis spectrophotometry method is valid for determining the paracetamol content and all samples meet the Pharmacopeia Indonesia requirements.
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