| DOI: 10.29090/psa.2021.06.21.017 | Pharm Sci Asia 2021; 48(6), 557-566 |
HPLC and chemometrics-assisted spectroscopic methods used for determination of dissolution of paracetamol and orphenadrine citrate in a combination tabletSuttikan Sonchai1, Chutima Phechkrajang2, Piyanuch Rojsanga2*
1 Center of Analysis for Product Quality, Faculty of Pharmacy, Bangkok, Thailand
2
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Mahidol University, Bangkok, Thailand
Simultaneous determination of paracetamol and orphenadrine citrate by high-performance liquid chromatographic (HPLC) and chemometric-assisted spectroscopic methods are described. The HPLC method was based on RP C18 column (5 μm, 4.6 mm×150 mm) using monobasic ammonium phosphate, methanol, and acetonitrile (400:450:150v/v/v) as a mobile phase. The flow rate was set at 1.5 mL/min with column temperature at 40°C and UV detection at 215 nm. Paracetamol and orphenadrine citrate were separated within 7 mins by an isocratic elution. Good linearities were obtained in concentration ranges of 5-150 μg/mL for paracetamol and 0.8-12 μg/mL for orphenadrine citrate, with correlation coefficients (r)>0.99. Recovery of the analytical method was acceptable (102.8-104.8% for paracetamol and 92.4-102.3% for orphenadrine citrate). Relative standard deviations (RSDs) of repeatability and intermediate precision were less than 2.0%. Likewise, the resolution has been completed by using partial least square regression applying UV spectrum. The successive partial least squares regression (PLSR) methods were used with UV spectra data of 200-400 nm and 5 latent factors for paracetamol and orphenadrine citrate. Finally, the developed methods proved to be suitable to assay the dissolution samples of paracetamol and orphenadrine citrate in the combination tablet.
Keyword:
Paracetamol, Orphenadrine, HPLC-PDA, Partial least squares regression, Multicomponent analysis
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