Novel Green Method for the Spectrophotometric Determination of Metoclopramide Hydrochloride in Pharmaceutical Formulations

Abstract

A less environmentally harmful reagent, 2-tert-Butyl-4-methoxyphenol (BHA), is used to evaluate Metoclopramide hydrochloride (MCP.H) by simple, rapid, sensitive, accurate and precise spectrophotometric method, through azo coupling reaction between metoclopramide hydrochloride medicine and it's pharmaceutical preparation by utilizing BHA as a reagent, (MCP.H) azo-dye formed shows the higher absorption peak at 504 nm. Absorbance- concentration relation is linear over the range from 20 to 280 µg / 5 mL, (i.e. 4-56 ppm) with a good sensitivity (molar absorptivity 0.26x104 L.mol-1. cm-1); good precision (RSD better than 0.844 %) and high accuracy (relative error less than + 0.4%), Sandell's sensitivity index is -0.1293 µg.cm-2, the calculated limit of detection (LOD) is 0.0658 µg/mL and the evaluated limit of quantitation (LOQ) is 0.2193 µg/mL. The application has had successful results for the assay of metoclopramide hydrochloride in dosage forms of tablets and injection.

Keywords

• butylated hydroxyanisole
• metoclopramide hydrochloride
• spectrophotomety
• friendly environment

Thanks

The authors express their honest thanks to Department of Chemistry and New and Renewable Energies, College of Science, University of Mosul, Mosul, Iraq to benefit the research facilities.

References

1. 1. Martindale W. The Extra Pharmacopoeia [Internet]. Creative Media Partners, LLC; 2018.
2. 2. El-Sonbaty MM, Ismail HR, Kassem AA, Samy AM, Akl MA. Mucoadhesive thermoreversible formu-lation of metoclopramide for rectal administration: a promising strategy for potential management of chemotherapy-induced nausea and vomiting. Pharm Devel Technol. 2020 May 27;25(5):535–46.
3. 3. Thanoon E, Saeed A. Development of Green Spectrophotometric Method for Determination of Metoclopramide Hydrochloride. Egypt J Chem. 2021 Mar 9;64(7):3451–6.
4. 4. Devi OZ, Basavaiah K, Vinay KB. Application of potassium permanganate to spectrophotometric assay of metoclopramide hydrochloride in pharmaceuticals. J Appl Spectrosc. 2012 Jan;78(6):873–83.
5. 5. Wasan Abdulameer Al-Uzri LD, Hadi H, Fadhel L. Spectrophotometric Determination of Metochlo-pramide in itsPharmaceutical Preparations using Diazotization Coupling Reaction. Iraqi Nat J Chem. 2015;15(2):175–90.
6. 6. Begum M, Koki IB, Rizwan M, Syed AA. Sensitive and Selective Spectrophotometric Methods for the Determination of Cisaprid, Metoclopramide Hydrochloride, Sulphadoxine and Sulphamethoxazole. Int J Chem Mater Environ Res. 2016;3(4):84–90.
7. 7. Abd-Alrassol KS, Qasim QA, AL-Rikabi MA, AL-Salman HNK. The development of analytical methods to determine metoclopramide hydrochloric acid in the standard raw and it compared with pharmaceuticals. Int J Res Pharm Sci. 2019;10(4):1–14.
8. 8. Abdulkareem HM, Al-Tameemi M, Ibraheem IH, Hadi MS. Surfactant cloud point extraction as a procedure of preconcentrating for metoclopramide determination using spectro analytical technique. Baghdad Sci J. 2020;17(1):57–65.

9. 9. Ganduh SH, Aljeboree AM, Mahdi MA, Jasim LS. Spectrophotometric Determination of Metoclopramide- HCl in the standard raw and it compared with pharmaceuticals. J Pharm Neg Res. 2021 Jan 2;21(2):44–8.
10. 10. Mubder NS, Kadhim EA, Ibraheem IH, Mahmood H, Dhahir SA, Al-Neshmi H. Micro Spectrophotometric Determination and Cloud Point Extraction of Metoclopramide with 4-Nitro Phenol in Pure Form and Pharmaceutical Drugs. Ann Roman Soc Cell Biol. 2021;25(4):12088–103.
11. 11. Abbas SM, Jamur JMS, Nasif AM. Spectrophotometric Method for the Determination of Metoclopramide in Pharmaceutical Forms. J Appl Spectrosc. 2021 May;88(2):433–40.
12. 12. Salih E, Mohamad I, Al-Najafi S. spectrophotometric Assay of Metoclopramide Hydrochloride in pharmaceutical preparations via oxidative coupling Reaction with proma zine Hydrochloride and N-Bromosuccinimide. J Edu Sci. 2006 Sep 1;18(3):10–9.
13. 13. Khaleel AI, Amine ST, Salih SH. Comparative study for determination of metoclopramide hydrochloride drug by selective electrodes and spectrophotometric methods. Tikrit J Pure Sci. 2013;18(1):149–61.
14. 14. Al-Shirifi AN, Dikran SB, Halboos MH. Application of central composite design method to oxidative coupling spectrophotometric determination of metoclopramide hydrochloride in pure form and pharmaceutical preparations. J Global Pharma Technol. 2018;10(5):143–52.
15. 15. Ali R, Othman N. Spectrophotometric Determination of Metoclopramide Hydrochloride in Pharmaceutical Preparations Via Schiff’s Base Reaction: In Mosul, Ninevah, Iraq; 2021 [cited 2023 Feb 5].
16. 16. Liu J, Li H, Wang Y. Spectrophotometric determination of metoclopramide based on the charge transfer reaction between metoclopramide and purpurin. Fenxi Kexue Xuebao. 2010;26(3):361–3.
17. 17. Ahmed NR, Essa MJ, Hamdoon AK. Ultraviolet assay of metoclopramide HCl in pharmaceutical formulations application to content uniformity testing. Eur J Biomed Pharm Sci. 2020;7(1):191–5.
18. 18. Okram Zenita Devi, Kanakapura Basavaiah, Kanakapura Basavaiah Vinay, Hosakere Doddarevanna Revanasiddappa. Determination of Metoclopramide Hydrochloride in Pharmaceuticals and Spiked Human Urine through Diazotization Reaction. J Food Drug Anal. 2012 Jan 1;20(2):454–63.
19. 19. Saleem BA. Spectrophotometric determination of some drugs using oxidation reduction reactions. Ibn Al-Haitham J Pure Appl Sci. 2019;32(3):43–55.
20. 20. Mashkour MS, Kahlol MK, AL-Hasnawi SW. Colorimetric Determination of Metoclopramide Hydrochloride and Glutathione by using 1,2 Naphthaquinolinc-4-Sulphonate Sodium Reagents. Res J Pharm Technol. 2018;11(8):3290–4.
21. 21. Valavala Sr SN, Tondepu S, Kandagatla S. LC-MS characterization of acid degradation products of metoclopramide: Development and validation of a stability-indicating RP-HPLC method. Int J Res Pharm Sci. 2020;11(1):781–9.
22. 22. Karaiskou SG, Kouskoura MG, Markopoulou CK. Modern pediatric formulations of the soft candies in the form of a jelly: determination of metoclopramide content and dissolution. Pharm Devel Technol. 2020 Jan 2;25(1):20–7.
23. 23. Khan A, Iqbal Z, Khan MI, Javed K, Khan A, Ahmad L, et al. Simultaneous determination of cefdinir and cefixime in human plasma by RP-HPLC/UV detection method: Method development, optimization, validation, and its application to a pharmacokinetic study. J Chrom B. 2011 Aug;879(24):2423–9.
24. 24. Vamshikrishna G, Neelima M, Bhavani M, Sreekanth G, Shobha S. A Simple Rp-Hplc method for simultaneous estimation of paracetamol and metoclopramide. HCl in tablet dosage form. IOSR J Pharm Biol Sci. 2014;9:69–78.
25. 25. Othman NS, Mahmood H, Khaleel N. Spectrophotometric and high performance liquid chromatographic methods for determination of metoclopramide in pharmaceutical preparations, Rafidain J. Sci. 2011;22:39–56.
26. 26. Al-Awadie NST, Al-banaa MAK. Determination of metoclopramide hydrochloride via quenched continuous fluorescence of fluorescein sodium salt molecule. J Pharm Sci Res. 2019;11(6):2312–21.
27. 27. Mazloum-Ardakani M, Kalantari AA, Alizadeh Z, Mohamadian-Sarcheshmeh H, Banitaba H. Electrochemical Investigation for Sensitive Determination of Metoclopramide Based on Ytterbium Oxide Nanoparticles Supported on Graphene. Anal Bioanal Chem Res. 2022;9(3):299–307.
28. 28. Guardia M de la, Garrigues S. Handbook of green analytical chemistry. Chichester, West Sussex Hoboken: John Wiley & Sons; 2012. ISBN: 978-1-119-94072-2.
29. 29. Casas Ferreira AM, Fernández Laespada ME, Pérez Pavón JL, Moreno Cordero B. Development of an environmentally friendly methodological approach to determine chlorinated hydrocarbons and chlorobenzenes in soils. Green Chem Lett Rev. 2014 Jan 2;7(1):50–9.
30. 30. Özgür M, Kalaycioğlu Z, Dülger Ö. Simultaneous spectrophotometric determination of phenolic antioxidant (BHA and BHT) concentrations in pharmaceutical preparations and chewing gums using the H-point standard addition method. Macedon J Chem Chem Eng. 2017 Dec 21;36(2):211.
31. 31. Hargis LG. Analytical chemistry: Principles and techniques. 1988 Jan; Available from:
32. 32. British Pharmacopoeia Commission. British pharmacopoeia. 2016. London: The Stationery Office; 2015.
33. 33. Christian GD, Dasgupta PK, Schug K. Analytical chemistry. Seventh edition. Hoboken, NJ: John Wiley and Sons, Inc.; 2014. ISBN: 978-1-118-80527-5.
34. 34. Abd Alrada WA, Sulaiman ID. Determination of Metochloropramide Hydrochloride by spectrophotometric method by using diazotized p-nitroaniline reagent. International J Drug Del Technol. 2020;10:68–73.