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Implementation of white analytical chemistry-driven analytical quality risk assessment and design of experiments to multipurpose chromatographic method for the synchronous estimation of multiple drugs co-formulated with paracetamol

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Abstract

In the pharmaceutical industry, several fixed-dose paracetamol combinations have been manufactured and marketed. Several chromatographic methods have been documented in the literature for the quality control of these fixed-dose combinations (FDCs). Yet, these chromatographic procedures were developed using teratogenic and neurotoxic organic solvents that are harmful to the environment and dangerous to human and animal life. As a result, a multipurpose chromatographic technique was developed combining principles of white analytical chemistry, quality risk assessment, and experimental design. To reduce the time and cost of analysis, this chromatographic method needs a single chromatographic condition for the quality control of multiple FDCs of paracetamol. To safeguard the environment and human life, the suggested chromatographic process employs low-toxicity possible solvents. The analytical quality risk assessment methodology by Placket‒Burman design was used to identify significant analytical method risk parameters and analytical quality attributes. Response surface analysis by mixture design was used to optimize the identified critical method risk parameters. Using unique principles of white analytical chemistry, the proposed and published chromatographic techniques were assessed for their validation efficiency, greenness profile, time efficiency, and cost efficiency for the estimation of FDCs of paracetamol with multiple drugs.

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References

  1. Nowak MP, Weitecha-Posluszny R, Pawliszyn J (2021) White analytical chemistry: an approach to reconcile the principles of green analytical chemistry and functionality. Trends Anal Chem 138:116223. https://doi.org/10.1016/j.trac.2021.116223

    Article  CAS  Google Scholar 

  2. International Council for Harmonization (2016) Q3C (R6) Impurities: a guideline for residual solvent. Geneva, 1–40.

  3. Indian Pharmacopoeia 2018, Volume I, Residual Solvents. Indian Pharmacopeia Commission, Ghaziabad, pp 987.

  4. Byrne FP, Jin S, Paggiola G (2016) Tools and techniques for solvent selection: green solvent selection guides. Sustain Chem Proces 4(7):1–24. https://doi.org/10.1186/s40508-016-0051-z

    Article  CAS  Google Scholar 

  5. Patel A, Shah SA (2022) DoE-based analytical quality risk management for enhanced AQbD approach to economical and eco-friendly RP-HPLC method for synchronous estimation of multiple FDC products of antihypertensive drugs. J Chromatogr Sci 60(8):786–799. https://doi.org/10.1093/chromsci/bmab123

    Article  CAS  PubMed  Google Scholar 

  6. Shahi A, Acharya A, Shah SA (2023) Chemometric and design of experiments based analytical quality by design and green chemistry approaches to the multipurpose high-pressure liquid chromatographic method for synchronous estimation of multiple fixed-dose combinations of azilsartan medoxomil. J AOAC Int 106(1):250–260. https://doi.org/10.1093/jaoacint/qsac086

    Article  Google Scholar 

  7. Patel A, Shah SA (2022) DoE-based analytical-FMCEA for enhanced AQbD approach to MEER-RP-HPLC method for synchronous estimation of fifteen antihypertensive pharmaceutical dosage forms. J AOAC Int 105(1):34–45. https://doi.org/10.1093/jaoacint/qsab097

    Article  PubMed  Google Scholar 

  8. Jayswal K, Shah SA (2021) Estimation of multiple fixed-dose combination products of ramipril and aspirin by GERV-chromatography using DoE and risk-based enhanced analytical quality by design approach. J AOAC Int 104(6):1726–1741. https://doi.org/10.1093/jaoacint/qsab073

    Article  PubMed  Google Scholar 

  9. Tailor PM, Shahi A, Acharya A, Shah SA (2022) Application of chemometry and design of experiments to green HPTLC method for synchronous estimation of multiple FDCs of cilnidipine. J AOAC Int 105(5):1493–1501. https://doi.org/10.1093/jaoacint/qsac056

    Article  Google Scholar 

  10. Ahir H, Prajapati B, Shah S (2023) Chemometric-based AQbD and green chemistry approach to the chromatographic analysis of remogliozin etabonate and vildagliptin. J AOAC Int 106(1):239–249. https://doi.org/10.1093/jaoacint/qsac084

    Article  Google Scholar 

  11. Patel A, Shah SA (2021) Application of DoE-based analytical QRM to development of the multipurpose RP-HPLC method for estimation of multiple FDC products of telmisartan using enhanced AQbD approach. J Chromatogr Sci 60(6):525–537. https://doi.org/10.1093/chromsci/bmab070

    Article  CAS  Google Scholar 

  12. Bagul N, Kalyankar G (2021) Implementation of DoE and risk-based enhanced analytical quality by design approach to stability indicating RP-HPLC method for stability study of bosutinib. J AOAC Int 104(6):1742–1753. https://doi.org/10.1093/jaoacint/qsab078

    Article  PubMed  Google Scholar 

  13. Patel A, Shah SA (2021) Risk and DoE-based DMAIC principle to the multipurpose-RP-HPLC method for synchronous estimation of anti-hypertensive drugs using AQbD approach. J AOAC Int 104(5):1442–1452. https://doi.org/10.1093/jaoacint/qsab079

    Article  PubMed  Google Scholar 

  14. Mistry KY, Shah SA (2022) DoE-based analytical failure modes critical effect analysis (AFMCEA) to a multipurpose-RP-HPLC method for the estimation of multiple FDC products of metformin hydrochloride using an analytical quality by design approach. J AOAC Int 105(4):986–998. https://doi.org/10.1093/jaoacint/qsac025

    Article  PubMed  Google Scholar 

  15. Patel AS, Shah SA (2023) Simultaneous estimation of telmisartan, chlorthalidone, amlodipine besylate and atorvastatin by RP-HPLC method for synchronous assay of multiple FDC products using analytical FMCEA-based AQbD approach. J Chromatogr Sci 61(2):160–171. https://doi.org/10.1093/chromsci/bmac030

    Article  CAS  PubMed  Google Scholar 

  16. Jayswal KV, Shah SA (2021) DoE and risk-based DMAIC principle for implementation of enhanced analytical quality by design approach to the multipurpose-chromatography method for simultaneous estimation of multiple fixed-dose combination products of aspirin. J AOAC Int 104(5):1430–1441. https://doi.org/10.1093/jaoacint/qsab058

    Article  PubMed  Google Scholar 

  17. Thakor MA, Bodiwala KB, Shah SA (2021) Quality risk management-based AQbD approach to the development of VEER chromatography method for the estimation of multiple combined formulations of anti-hypertensive drugs. J AOAC Int 104(3):605–619. https://doi.org/10.1093/jaoacint/qsaa140

    Article  PubMed  Google Scholar 

  18. Patel NM, Shah SA (2022) Implementation of DMAIC principle-based analytical quality by design approach to simultaneous estimation of metronidazole and ofloxacin by HPTLC method. J Iranian Chem Soc 19:2915–2928. https://doi.org/10.1007/s13738-022-02503-0

    Article  CAS  Google Scholar 

  19. Patel PR, Shah SA (2022) Chemometric and DoE-based analytical quality risk management to HPTLC method for simultaneous estimation of metronidazole and norfloxacin. J Chromatogr Sci. https://doi.org/10.1093/chromsci/bmab145

    Article  PubMed  Google Scholar 

  20. Naik K, Tailor P, Shah SA (2022) Screening design and response surface methodology for the simultaneous estimation of carvedilol and ivabradine HCl by HPTLC method. J Chromatogr Sci 60(9):859–870. https://doi.org/10.1093/chromsci/bmab130

    Article  CAS  PubMed  Google Scholar 

  21. Patel U, Shah SA (2022) Fractional factorial and central composite design for implementation of risk and DoE-based enhanced AQbD approach to eco-friendly HPTLC method for estimation of dalfampridine in pharmaceutical dosage forms and human plasma. J Iranian Chem Soc 19:2263–2277. https://doi.org/10.1007/s13738-021-02445-z

    Article  CAS  Google Scholar 

  22. Patel M, Shah SA (2021) A robust high-performance thin-layer chromatography method for the simultaneous estimation of chlorthalidone and metoprolol succinate using quality risk assessment and design of experiments-based enhanced analytical quality by design approach. JPC-J Planar Chromat-Mod TLC 34:229–242. https://doi.org/10.1007/s00764-021-00107-7

    Article  CAS  Google Scholar 

  23. Patel A, Mishra A (2021) Risk and DoE-based analytical failure mode effect analysis (AFMEA) to simultaneous estimation of montelukast sodium and bilastine by HPTLC method using enhanced AQbD approach. J Chromatogr Sci 60(6):595–605. https://doi.org/10.1093/chromsci/bmab107

    Article  CAS  Google Scholar 

  24. Tailor P, Shahi A, Acharya A, Shah SA (2022) Application of Taguchi OA and Box-Behnken design for the implementation of DoE-based AQbD approach to HPTLC method for simultaneous estimation of azilsartan and cilnidipine. J Chromatogr Sci. https://doi.org/10.1093/chromsci/bmac045

    Article  PubMed  Google Scholar 

  25. Radadiya K, Shah SA (2022) Principal component analysis and DoE-based AQbD approach to multipurpose HPTLC method for synchronous estimation of multiple FDCs of metformin HCl, repaglinide, glibenclamide and pioglitazone HCl. J Chromatogr Sci. https://doi.org/10.1093/chromsci/bmac055

    Article  Google Scholar 

  26. Drug data bank for paracetamol, caffeine, etoricoxib, aceclofenac, aspirin, nabumetone. https://go.drugbank.com/drugs/DB00316, DB00201, DB01628, DB06736, DB00945, DB00461. Accessed 20 Mar 2023.

  27. Narayanan VL, Austin A (2016) Determination of acetaminophen and caffeine using reverse phase liquid (RP-LC) chromatographic technique. J Res Pharm Sci 3(4):5–10

    Google Scholar 

  28. Acheampong A, Addai-Arhin S, Apau J, Gyasi WO (2015) Development and validation of RP-HPLC method with PDA detection for simultaneous estimation of acetylsalicylic acid, paracetamol and caffeine in fixed-dose combination tablets. Int J Chem Biomol Sci 1(4):211–217

    CAS  Google Scholar 

  29. Pattan SR, Jamdar SG, Godje RK, Daithankar AV, Nirmal SA, Pai MG (2009) RP-HPLC method for simultaneous estimation of paracetamol and etoricoxib from bulk and tablets. J Chem Pharm Res 1(1):329–335

    CAS  Google Scholar 

  30. Gopinath R, Rajan S, Meyyannathan SN, Krishnaveni N, Suresh B (2007) A RP-HPLC method for simultaneous estimation of paracetamol and aceclofenac in tablets. Indian J Pharm Sci 69(1):137–140. https://doi.org/10.4103/0250-474X.32130

    Article  CAS  Google Scholar 

  31. Tsvetkova BG, Pencheva IP, Peikov PT (2012) RP-HPLC method for simultaneous determination of paracetamol and aspirin in tablets. Int J Biol Pharm Allied Sci 1(7):913–917

    Google Scholar 

  32. Oza CK, Ranju N, Pandya MK, Vyas AJ, Patel AI (2012) A RP-HPLC method for the simultaneous estimation of paracetamol and nabumetone in API and tablet dosage form. Asian J Res Chem 5(9):1118–1122

    Google Scholar 

  33. Alam P, Shakeel F, Ali A, Alqarni MH (2022) Simultaneous determination of caffeine and paracetamol in commercial formulations using greener normal-phase and reversed-phase HPTLC method. Molecules 27(2):405–410. https://doi.org/10.3390/molecules27020405

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  34. Dhaneshwar SR, Raut KO, Bhusari VK (2011) Validated HPTLC method for simultaneous estimation of paracetamol and etoricoxib in bulk drug and formulation. Asian J Pharm Biol Res 1(2):87–93

    Google Scholar 

  35. Harikrishnan N, Gunasekaran V, Satishbabu A, Rao GS, Roosewelt C (2007) Simultaneous estimation of aceclofenac and paracetamol by HPTLC in pure and pharmaceutical dosage form. Asian J Chem 19(5):3918–3922

    CAS  Google Scholar 

  36. Sakur AA, Mannaa F, Eddin MY (2021) Preparing new chromatographic support from local Syrian clay and using it in thin layer chromatography for simultaneous determination of paracetamol, aspirin and caffeine in tablets. Res J Pharm Tech 14(4):2119–2124. https://doi.org/10.52711/0974-360X.2021.00375

    Article  Google Scholar 

  37. Gandhi SV, Ranher SS, Deshpande PB, Shah DK (2011) Simultaneous HPTLC determination of nabumetone and paracetamol in combined tablet dosage form. J Brazilian Chem Soc 22(6):1068–1072. https://doi.org/10.1590/S0103-50532011000600010

    Article  CAS  Google Scholar 

  38. Dispas A, Avohou HT, Lebrun P, Hubert P, Hubert C (2018) Quality by design approach for the analysis of impurities in pharmaceutical drug products and drug substances. TrAC Trends Anal Chem 101:24–33

    Article  CAS  Google Scholar 

  39. Rozet E, Lebrun P, Hubert P, Debrus B, Boulanger B (2013) Design spaces for analytical methods. TrAC Trends Anal Chem 42:157–167

    Article  CAS  Google Scholar 

  40. Gałuszka A, Migaszewski ZM, Konieczka P, Namieśnik J (2012) Analytical eco-scale for assessing the greenness of analytical procedures. TrAC Trends Anal Chem 37:61–72

    Article  Google Scholar 

  41. Pena-Pereira F, Wojnowski W, Tobiszewski M (2020) AGREE—analytical GREEnness metric approach and software. Anal Chem 92(14):10076–10082

    Article  CAS  PubMed  PubMed Central  Google Scholar 

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Acknowledgements

The authors are grateful to the principal of Maliba Pharmacy College and the provost of Uka Tarsadia University for providing the required equipment, resources, and infrastructure to carry out the suggested research effort.

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Authors and Affiliations

  1. Department of Quality Assurance, Maliba Pharmacy College, Maliba Campus, Bardoli-Mahuva Road, Tarsadi, Mahuva, Surat, Gujarat, 394350, India

    Pintu Prajapati, Minal Salunkhe & Shailesh Shah

  2. Department of Chemistry and Biochemistry, Ohio University, Anthens, OH, 45701, USA

    Veerashakar Pulusu

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  1. Pintu Prajapati
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Correspondence to Pintu Prajapati.

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Prajapati, P., Salunkhe, M., Pulusu, V. et al. Implementation of white analytical chemistry-driven analytical quality risk assessment and design of experiments to multipurpose chromatographic method for the synchronous estimation of multiple drugs co-formulated with paracetamol. JPC-J Planar Chromat 37, 69–86 (2024). https://doi.org/10.1007/s00764-023-00262-z

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