Capillary zone electrophoresis as a quality assessment tool of paracetamol and phenylephrine hydrochloride in presence of paracetamol impurities
Capillary zone electrophoresis as a quality assessment tool of paracetamol and phenylephrine hydrochloride in presence of paracetamol impurities
The combination of paracetamol (PAR) and phenylephrine HCl (PHE) is a common pharmaceutical combination intended to manage symptoms of every day cold. Since paracetamol is susceptible to degradation or some manufacturing-related impurities, its stability should be monitored continuously. The developed method in this study for the determination of PAR and PHE in presence of PAR impurities is considered a quality assessment tool especially when PAR impurities can be quantitatively determined. A capillary zone electrophoresis (CZE) method was optimized and validated for simultaneous determination of PAR and PHE in presence of PAR impurities namely, p-Aminophenol (PAP), p-Nitrophenol (PNP), Acetanilide (ACT) and p-Chloroacetanilide (CAC) with further quantification of these toxic impurities. Factors that affect the separation quality such as pH, buffer and applied voltage were optimized. The separation was carried out using 20 mM phosphate buffer (pH 8). The linearity was reached over concentration ranges of 30–250 μg/ mL, 1–40 μg/mL, 2–50 μg/mL, 2–50 μg/mL, 2–50 μg/mL and 2–50 μg/mL for PAR, PHE, PAP, PNP, ACT, and CAC, respectively, with accuracy ranging from 99.06% to 100.62%. After validation, the method was applied for pharmaceutical formulation analysis with RSD
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- 1. British pharmacopoeia. British Pharmacopoeia. 5th ed. Buckingham Palace Road, London, UK: Stationary Office, Appendix 1D; 2016.
- 2. The united states of pharmacopoeia-39/ national formulary-34. Rockville, Maryland, USA: United States Pharmacopoeial Convention, Inc.; 2016.
- 3. Sweetman SC. Martindale: The complete drug reference. 37th ed. London, UK: Pharmaceutical Press; 2011.
- 4. Fowler LM, Moore RB, Foster JR, Lock EA. Nephrotoxicity of 4-aminophenol glutathione conjugate. Human & Experimental Toxicology 1991; 10 (6): 451-459.
- 5. Braimah HY, Tijjani AB, Amos SC. Impurity profiling of paracetamol dosage forms used in maiduguri metropolis. World Journal of Pharmaceutical Research 2019; 8 (9): 1659-1685.
- 6. El Sherbiny D, Wahba ME. Analysis of some pharmaceuticals in the presence of their synthetic impurities by applying hybrid micelle liquid chromatography. Open Chemistry 2020; 18 (1): 377-390.
- 7. Abdelwahab NS, Abdelrahman MM, Boshra JM, Taha AA. Different stability-indicating chromatographic methods for specific determination of paracetamol, dantrolene sodium, their toxic impurities and degradation products. Biomedical Chromatography 2019; 33 (9): 1-9.
- 8. Alizadeh T, Ganjali MR, Norouzi P, Zare M, Zeraatkar A. A novel high selective and sensitive para-nitrophenol voltammetric sensor, based on a molecularly imprinted polymer–carbon paste electrode. Talanta 2009; 79 (5): 1197-1203.
- 9. Brodie BB, Axelrod J. The fate of acetanilide in man. Journal of Pharmacology and Experimental Therapeutics 1948; 94 (1): 29-38.
- 10. Rankin GO, Valentovic MA, Beers KW, Nicoll DW, Ball JG et al. Renal and hepatic toxicity of monochloroacetanilides in the fischer 344 rat. Toxicology 1993; 79 (3): 181-193.
- 11. Demiralay EÇ, Gümüştaş M, Canbay H. Validation of method for simultaneous determination of paracetamol and phenylephrine in pharmaceutical formulation by reversed phase liquid chromatography. International Journal of Comprehensive Pharmacy 2011; 2 (6): 1-4.
- 12. Farid JF, Mostafa NM, Fayez YM, Essam HM. Systemic optimization and validation of normal and reversed-phase eco-friendly chromatographic methods for simultaneous determination of paracetamol and phenylephrine hydrochloride in the presence of paracetamol impurities. Journal of AOAC International 2021; doi: 10.1093/jaoacint/qsab119.
- 13. Chavada VD, Bhatt NM, Sanyal M, Shrivastav PS. Comparative evaluation of four spectrophotometric methods for the simultaneous determination of paracetamol and phenylephrine hydrochloride in fixed dose pharmaceutical formulations. Physical Chemistry 2015; 17(1): 6-15.
- 14. Farid JF, Essam HM, Mostafa NM, Fayez YM. Spectral manipulation of ratio data for simultaneous determination of binary mixture of paracetamol and phenylephrine hydrochloride. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 2021; 260: 119894.
- 15. Farid JF, Mostafa NM, Fayez YM, Essam HM, ElTanany BM. Chemometric quality assessment of paracetamol and phenylephrine hydrochloride with paracetamol impurities; comparative uv-spectrophotometric implementation of four predictive models. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy 2021:120308.
- 16. Lotfi S, Veisi H. Pd nanoparticles decorated poly-methyldopa@ go/fe3o4 nanocomposite modified glassy carbon electrode as a new electrochemical sensor for simultaneous determination of acetaminophen and phenylephrine. Materials Science and Engineering C 2019; 105: 110-112.
- 17. Weston A, Brown PR. High performance liquid chromatography & capillary electrophoresis: Principles and practices. San Diego, California, USA: Elsevier; 1997; 7-15.
- 18. Adamovics JA. Chromatographic analysis of pharmaceuticals. CRC Press; 1996; 11-17.