Abstract:
Objective To improve the quality standard of paracetamol tablets, one of the products under the national drug quality consistency evaluation program, this study established a method for the simultaneous determination of the main drug substance, specified impurities, and preservatives in paracetamol tablets.
Methods High-performance liquid chromatography(HPLC) was performed using a Caprisil C
18-P column(150 mm × 4.6 mm, 5 μm) with methanol-water as the mobile phase for gradient elution at a flow rate of 1 mL·min
-1, detection wavelength of 245 nm, column temperature of 30 ℃, and injection volume of 20 μL. The external standard method was used for quantitative analysis.
Results The chromatographic conditions were optimized, and the main drug substance(paracetamol), two specified impurities(
p-aminophenol and
p-chloroacetanilide), as well as three preservatives(methylparaben, ethylparaben and propylparaben) were effectively separated and accurately quantified. The linear ranges of mass concentrations for paracetamol,
p-aminophenol,
p-chloroacetanilide, methylparaben, ethylparaben, and propylparaben were 5.012 5 ~300.75, 0.102 2 ~ 4.088, 0.040 3 ~ 1.008, 0.200 4 ~ 4.007, 0.020 26 ~ 0.808 6, 0.048 58 ~ 0.607 2 mg·L
-1, respectively(
r ≥ 0.999 6). The limits of detection were 0.003 00, 0.010 22, 0.010 08, 0.040 07, 0.003 04, and 0.014 57 mg·L
-1, and the limits of quantification were 0.010 02, 0.040 88, 0.040 30, 0.100 20, 0.010 13, and 0.048 58 mg·L
-1, respectively. The average recoveries at different spiked concentration levels ranged from 95.50% to 108.82%, with relative standard deviation(RSD,
n = 6) between 0.13% and 4.33%.
Conclusion This method exhibits strong specificity, high accuracy, high efficiency, and simplicity. It can be applied to the simultaneous determination of the main drug substance, specified impurities and preservatives in paracetamol tablets, and provides a basis for improving the quality of paracetamol tablets.