SIMULTANEOUS DETERMINATION OF NAPROXEN SODIUM AND ACETAMINOPHEN IN FIXED-DOSE COMBINATIONS FORMULATIONS BY FIRST-ORDER DERIVATIVE SPECTROSCOPY: APPLICATION TO DISSOLUTION STUDIES
Keywords:
Naproxen sodium, Acetaminophen, First-order derivative spectroscopy, Zero-crossing method, Fixed-dose combinations formulationsAbstract
Objective: To validate and apply a new and easy zero-crossing derivative method for the simultaneous determination of naproxen sodium and acetaminophen in fixed-dose combinations formulations.
Methods: Measurement was achieved using the first-derivative (1D) signals at 243.42 nm for naproxen sodium and at 297.10 nm for acetaminophen. The method was validated according to International Conference on Harmonization (ICH) guidelines and was used to obtain the dissolution profiles (USP Apparatus 2, 75 rpm and 900 ml of 0.1 M phosphate buffer pH 7.4) of five generic products and the reference product Febrax® (275/300 mg of naproxen sodium and acetaminophen, respectively). Dissolution data: percent of drug dissolved at 60 min, mean dissolution time (MDT) and dissolution efficiency (DE) were compared by a univariate one-way analysis of variance (ANOVA) followed by Dunnett's multiple comparisons test. Differences were considered significant if *P<0.05. Additionally, data were adjusted to different kinetic models.
Results: The method was linear (R2>0.99, *P<0.05) in the range of 10–50 µg/ml and 100–300 µg/ml for naproxen sodium and acetaminophen, respectively. The within-day and between-day precision and accuracy were within the acceptable criteria (relative standard deviation (RSD)<3% and 100±3%). Significant differences in MDT and DE values from all studies products were found (*P<0.05). All dissolution profiles were adjusted to Weibull's kinetics and significant differences in Td values were found (*P<0.05).
Conclusion: The proposed derivative spectrophotometry method can be used for the simultaneous determination of naproxen sodium and acetaminophen in dissolution studies. The method is rapid, simple, accurate, and precise without the need of high cost investment.
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References
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