Research Article
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Determination of Micro Amounts of Promethazine Hydrochloride in Pure and Pharmaceutical Samples Using UV- Visible Spectrophotometry

Year 2024, , 19 - 30, 04.02.2024
https://doi.org/10.18596/jotcsa.1286566

Abstract

This study presents the development of a novel, facile, and overly sensitive spectrophotometric approach for quantifying promethazine hydrochloride (PRO) within its pharmaceutical formulations. The method capitalizes on an oxidative coupling reaction, achieved through the oxidation of the compound in an acidic milieu utilizing ammonium cerium (IV) sulfate dehydrate (Ce+4) solution. This process leads to the creation of a green-colored solution, which, upon conjugation with 5-aminosalicylic acid, exhibits maximum absorption at a wavelength of 598 nm. The methodology investigated several parameters, encompassing oxidation duration, temperature, quantities of oxidizing agent and coupling reagent, and determining the stoichiometric ratio between promethazine hydrochloride and 5-aminosalicylic acid. The established ratio was confirmed to be 1:1. Numerous organic solvents were evaluated, with water emerging as the optimal choice due to its pronounced absorption characteristics at the 598 nm wavelength. The applicability of Beer's law was verified over a concentration range of 2 - 28 μg/mL of promethazine hydrochloride, with a calculated molar absorption coefficient of 1.9606 x 104 L/mol∙cm. The Sandell sensitivity index was determined as 0.0164 μg/cm2, while the relative standard deviation (RSD) ranged from 0.8553- 1.2671%. Notably, recovery percentages were also within the 99.88 – 100.34% range. The efficacy of this technique was effectively demonstrated through its successful application in the analysis of pharmaceutical formulations containing promethazine hydrochloride, employing the standard method as a benchmark.

Supporting Institution

Tikrit university / College of Engineering / Chemical Engineering Department

Thanks

The author would like to convey their gratitude and appreciation to the College of Engineering/University of Tikrit, specifically the Chemical Engineering Department, for the facilities and support offered for the research.

References

  • 1. Cantisani C, Ricci S, Grieco T, Paolino G, Faina V, Silvestri E, et al. Topical promethazine side effects: our experience and review of the literature. BioMed research international. 2013;1-9. Available from: <URL>
  • 2. Harvey RA, Clark M, Finkel R, Rey J, Whalen K. Lippincott’s illustrated reviews: Pharmacology: Philadelphia; 2012.
  • 3. Ballington DA, Laughlin MM. Pharmacology. 3rd Ed.; Printed at Swastic Packaging; Delhi-92 (India); 2008. Available from: <URL>
  • 4. Katzung BG. Basic & clinical pharmacology.14th edition; 2018; 1105 – 1106.
  • 5. Seth D, VimLesh S. Textbook of Pharmacology, 3rd Ed; Printed in India; 2009.
  • 6. Bennett PN, Brown MJ. Clinical Pharmacology. 10th Ed. the library of congress, Spain 2008.
  • 7. Pharmacopoeia B, Commission BP. The stationery office. London, UK. 2009;1(123,128).
  • 8. Badawy SS, El Said SAES. Promethazine-Tetraphenyl Boron (III) Modified Carbon Paste Electrode for the Determination of Promethazine Hydrochloride. 2013. Available from: <URL>
  • 9. Al-Saidi KH, Ahmed ZW. Construction of Promethazine Hydrochloride Selective Electrodes in A PVC Matrix Membrane. Journal of Al-Nahrain University. 2011;14(4):11-7. Available from: <URL>
  • 10. Sarma B, Seema R. An electrochemical characteristics of promethazine HCl using ion selective electrodes. Int J Curr Res. 2017;9(11):60523-5.
  • 11. Shakir IM, Turkey NS. Flow injection analysis for the photometric determination of promethazine-HCl in pure and pharmaceutical preparation via oxidation by persulphate using Ayah 3SX3-3D solar micro photometer. Baghdad Science Journal. 2013;10(4):1190-202. Available from: <URL>
  • 12. Shakir IM. Promethazine-HCl determination using entrapped persulphate in water crystals by flow injection/stopped-flow technique and Ayah 3SX3-3D solar cell micro photometer. Iraqi journal of science. 2015;56(1A):25-37. Available from: <URL>
  • 13. Jabbar HS, Faizullah AT. Flow injection analysis with chemiluminescence detection for determination of two phenothiazines. Int J Pharm Sci Res. 2015;6:474-81.
  • 14. Chaudhary J, Jain A, Saini V. Novel RP-HPLC method for estimation of paracetamol and promethazine simultaneously in syrup formulation. Journal of Research in Pharmacy. 2019;23(3):476-83. Available from: <URL>
  • 15. Saleh OA, El-Azzouny AA, Aboul-Enein HY, Badawy AM. A validated HPLC method for separation and determination of promethazine enantiomers in pharmaceutical formulations. Drug development and industrial pharmacy. 2009;35(1):19-25. Available from: <URL>
  • 16. Mahmood SS, Hashem OA, Khither MM. Determination of Promethazine Hydrochloride in pharmaceutical forms by Spectrophotometric Method. journal of kerbala university. 2018;14(3):28-38.
  • 17. Ahmed NR, Ahmed AI, Saadallah NC. Spectrophotometric estimation of promethazine hydrochloride in pharmaceutical preparations. European J Biomed Pharm Sci. 2020;7:79-84.
  • 18. Qader HA, Fakhre NA. Spectrophotometric determination of promethazine hydrochloride in pure and pharmaceutical dosage forms. ZJPAS. 2017;29:s107-s14.
  • 19. Abdulrahman LK, Al-Abachi AM, Al-Qaissy MH. Spectrophotmetric Micro determination of promrthazine hydrochloride in pharmaceutical. Baghdad Science Journal. 2005;2(3):471-6.
  • 20. Tagi RM, Al-Timimi RJ, Hassan MM, Hamzah MJ. Spectrophotometric determination of promethazine HCl in pure and dosage forms. Journal of Biotechnology Research Center. 2019;13(1):52-7. Available from: <URL>
  • 21. Al-Rufaie MMM. A sensitive spectrophotometric method for trace amounts determination of promethazine in drug formulations via ion pair complex formation. Malaysian Journal of Science. 2021:80-92. Available from: <URL>
  • 22. Al-Saidi KH, Hammza RA. Spectrophotometric determination of promethazine hydrochloride and paracetamol in pharmaceutical tablets. Al-Nahrain Journal of Science. 2014;17(1):14-23. Available from: <URL>
  • 23. M Al-Shaker Y. Spectrophotometric assay of metoclopramide hydrochloride in some pharmaceutical preparations via oxidation coupling reaction. Iraqi Journal of Pharmacy. 2013;13(1):41-50.
  • 24. Ahmed NR, Abdullah MS. Promethazine an environmental friendly reagent for novel estimation of hypochlorite in environmental samples. World Journal of pharmacy and Pharmaceutical Sciences. 2019;8(9):72-9.
  • 25. Al-Ward HS. Kinetic spectrophotometric methods for the determination of chloramphenicol in pharmaceutical preparations. Al-Nahrain Journal of Science. 2012;15(4):22-30. Available from: <URL>
  • 26. A AL-Da M, Al Q. A new colorimetric method for determination of procaine in pharmaceutical preparations via oxidative coupling organic reaction. journal of kerbala university. 2008;4(3):236-42.
  • 27. Mhemeed A. Spectrophotometric method for the determination of benzocaine by cerium ammonium sulphate with promethazine hydrochloride in pure and pharmaceuticals preparation. International Journal of Research in Pharmaceutical Sciences. 2019;10(2):1420-3. Available from: <URL>
  • 28. Humeidy IT. Spectrophotometric determination of cefotaxime sodium in pharmaceutical formulations. Materials Today: Proceedings. 2021;47:6043-9.
  • 29. Humeidy IT, Salman SA, Hashim KK. Spectrophotometric Determination of Methyldopa With 2, 6-Diaminopyridine Reagent Using Oxidative Coupling Reaction. Journal of Engineering Science and Technology. 2020;15(3):1824-39.
Year 2024, , 19 - 30, 04.02.2024
https://doi.org/10.18596/jotcsa.1286566

Abstract

References

  • 1. Cantisani C, Ricci S, Grieco T, Paolino G, Faina V, Silvestri E, et al. Topical promethazine side effects: our experience and review of the literature. BioMed research international. 2013;1-9. Available from: <URL>
  • 2. Harvey RA, Clark M, Finkel R, Rey J, Whalen K. Lippincott’s illustrated reviews: Pharmacology: Philadelphia; 2012.
  • 3. Ballington DA, Laughlin MM. Pharmacology. 3rd Ed.; Printed at Swastic Packaging; Delhi-92 (India); 2008. Available from: <URL>
  • 4. Katzung BG. Basic & clinical pharmacology.14th edition; 2018; 1105 – 1106.
  • 5. Seth D, VimLesh S. Textbook of Pharmacology, 3rd Ed; Printed in India; 2009.
  • 6. Bennett PN, Brown MJ. Clinical Pharmacology. 10th Ed. the library of congress, Spain 2008.
  • 7. Pharmacopoeia B, Commission BP. The stationery office. London, UK. 2009;1(123,128).
  • 8. Badawy SS, El Said SAES. Promethazine-Tetraphenyl Boron (III) Modified Carbon Paste Electrode for the Determination of Promethazine Hydrochloride. 2013. Available from: <URL>
  • 9. Al-Saidi KH, Ahmed ZW. Construction of Promethazine Hydrochloride Selective Electrodes in A PVC Matrix Membrane. Journal of Al-Nahrain University. 2011;14(4):11-7. Available from: <URL>
  • 10. Sarma B, Seema R. An electrochemical characteristics of promethazine HCl using ion selective electrodes. Int J Curr Res. 2017;9(11):60523-5.
  • 11. Shakir IM, Turkey NS. Flow injection analysis for the photometric determination of promethazine-HCl in pure and pharmaceutical preparation via oxidation by persulphate using Ayah 3SX3-3D solar micro photometer. Baghdad Science Journal. 2013;10(4):1190-202. Available from: <URL>
  • 12. Shakir IM. Promethazine-HCl determination using entrapped persulphate in water crystals by flow injection/stopped-flow technique and Ayah 3SX3-3D solar cell micro photometer. Iraqi journal of science. 2015;56(1A):25-37. Available from: <URL>
  • 13. Jabbar HS, Faizullah AT. Flow injection analysis with chemiluminescence detection for determination of two phenothiazines. Int J Pharm Sci Res. 2015;6:474-81.
  • 14. Chaudhary J, Jain A, Saini V. Novel RP-HPLC method for estimation of paracetamol and promethazine simultaneously in syrup formulation. Journal of Research in Pharmacy. 2019;23(3):476-83. Available from: <URL>
  • 15. Saleh OA, El-Azzouny AA, Aboul-Enein HY, Badawy AM. A validated HPLC method for separation and determination of promethazine enantiomers in pharmaceutical formulations. Drug development and industrial pharmacy. 2009;35(1):19-25. Available from: <URL>
  • 16. Mahmood SS, Hashem OA, Khither MM. Determination of Promethazine Hydrochloride in pharmaceutical forms by Spectrophotometric Method. journal of kerbala university. 2018;14(3):28-38.
  • 17. Ahmed NR, Ahmed AI, Saadallah NC. Spectrophotometric estimation of promethazine hydrochloride in pharmaceutical preparations. European J Biomed Pharm Sci. 2020;7:79-84.
  • 18. Qader HA, Fakhre NA. Spectrophotometric determination of promethazine hydrochloride in pure and pharmaceutical dosage forms. ZJPAS. 2017;29:s107-s14.
  • 19. Abdulrahman LK, Al-Abachi AM, Al-Qaissy MH. Spectrophotmetric Micro determination of promrthazine hydrochloride in pharmaceutical. Baghdad Science Journal. 2005;2(3):471-6.
  • 20. Tagi RM, Al-Timimi RJ, Hassan MM, Hamzah MJ. Spectrophotometric determination of promethazine HCl in pure and dosage forms. Journal of Biotechnology Research Center. 2019;13(1):52-7. Available from: <URL>
  • 21. Al-Rufaie MMM. A sensitive spectrophotometric method for trace amounts determination of promethazine in drug formulations via ion pair complex formation. Malaysian Journal of Science. 2021:80-92. Available from: <URL>
  • 22. Al-Saidi KH, Hammza RA. Spectrophotometric determination of promethazine hydrochloride and paracetamol in pharmaceutical tablets. Al-Nahrain Journal of Science. 2014;17(1):14-23. Available from: <URL>
  • 23. M Al-Shaker Y. Spectrophotometric assay of metoclopramide hydrochloride in some pharmaceutical preparations via oxidation coupling reaction. Iraqi Journal of Pharmacy. 2013;13(1):41-50.
  • 24. Ahmed NR, Abdullah MS. Promethazine an environmental friendly reagent for novel estimation of hypochlorite in environmental samples. World Journal of pharmacy and Pharmaceutical Sciences. 2019;8(9):72-9.
  • 25. Al-Ward HS. Kinetic spectrophotometric methods for the determination of chloramphenicol in pharmaceutical preparations. Al-Nahrain Journal of Science. 2012;15(4):22-30. Available from: <URL>
  • 26. A AL-Da M, Al Q. A new colorimetric method for determination of procaine in pharmaceutical preparations via oxidative coupling organic reaction. journal of kerbala university. 2008;4(3):236-42.
  • 27. Mhemeed A. Spectrophotometric method for the determination of benzocaine by cerium ammonium sulphate with promethazine hydrochloride in pure and pharmaceuticals preparation. International Journal of Research in Pharmaceutical Sciences. 2019;10(2):1420-3. Available from: <URL>
  • 28. Humeidy IT. Spectrophotometric determination of cefotaxime sodium in pharmaceutical formulations. Materials Today: Proceedings. 2021;47:6043-9.
  • 29. Humeidy IT, Salman SA, Hashim KK. Spectrophotometric Determination of Methyldopa With 2, 6-Diaminopyridine Reagent Using Oxidative Coupling Reaction. Journal of Engineering Science and Technology. 2020;15(3):1824-39.
There are 29 citations in total.

Details

Primary Language English
Subjects Analytical Chemistry
Journal Section RESEARCH ARTICLES
Authors

Israa Talib Humeidy 0000-0002-1656-1430

Publication Date February 4, 2024
Submission Date April 23, 2023
Acceptance Date October 2, 2023
Published in Issue Year 2024

Cite

Vancouver Humeidy IT. Determination of Micro Amounts of Promethazine Hydrochloride in Pure and Pharmaceutical Samples Using UV- Visible Spectrophotometry. JOTCSA. 2024;11(1):19-30.