Acta Pharmaceutica, Vol. 69 No. 2, 2019.
Original scientific paper
https://doi.org/10.2478/acph-2019-0017
Stability-indicating HPLC-PDA assay for simultaneous determination of paracetamol, thiamine and pyridoxal phosphate in tablet formulations
AMIR ALI
; Institute of Chemistry, University of the Punjab, Lahore 54590, Pakistan
MUHAMMAD MAKSHOOF ATHAR
; Institute of Chemistry, University of the Punjab, Lahore 54590, Pakistan
MAHMOOD AHMED
; Institute of Chemistry, University of the Punjab, Lahore 54590, Pakistan
KASHIF NADEEM
; Schazoo Pharmaceutical Laboratories, Lahore- Jaranwala Road, Sheikhupura, Pakistan
GHULAM MURTAZA
; Schazoo Pharmaceutical Laboratories, Lahore- Jaranwala Road, Sheikhupura, Pakistan
UMAR FAROOQ
orcid.org/0000-0003-0148-1013
; Institute of Chemistry, University of the Punjab, Lahore 54590, Pakistan
MUHAMMAD SALMAN
; Institute of Chemistry, University of the Punjab, Lahore 54590, Pakistan
Abstract
With the increased number of multi-drug formulations, there is a need to develop new methods for simultaneous determinations of drugs. A precise, accurate and reliable liquid chromatographic method was developed for simultaneous determination of paracetamol, thiamine, and pyridoxal phosphate in pharmaceutical formulations. Separation of analytes was carried out with an Agilent Poroshell C18 column. A mixture of ammonium phosphate buffer (pH = 3.0), acetonitrile and methanol in the ratio of 86:7:7 (V/V/V) was used as the mobile phase pumped at a flow rate of 1.8 mL min-1. Detection of all three components, impurities and degradation products was performed at the selected wavelength of 270 nm. The developed method was validated in terms of linearity, specificity, precision, accuracy, LOD and LOQ as per ICH guidelines. Linearity of the developed method was found in the range 17.5-30 µg mL–1 for thiamine, 35-60 µg mL–1 for pyridoxal phosphate and 87.5-150 µg mL–1 for paracetamol. The coefficient of determination was ≥0.9981 for all three analytes. The proposed HPLC method was found to be simple and reliable for the routine simultaneous analysis of paracetamol, thiamine and pyridoxal phosphate in tablet formulations. Complete separation of analytes in the presence of degradation products indicated selectivity of the method.
Keywords
paracetamol; thiamine; pyridoxine phosphate; degradation; HPLC-PDA
Hrčak ID:
209318
URI
Publication date:
30.6.2019.
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