DEVELOPMENT AND VALIDATION OF DOUBLE DIVISOR RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY METHOD FOR TERNARY MIXTURE OF DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PSEUDOEPHEDRINE HYDROCHLORIDE IN TABLET DOSAGE FORM

  • RIDA EVALINA TARIGAN Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Sumatera Utara, Medan, 20155, Indonesia
  • MUCHLISYAM Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Sumatera Utara, Medan, 20155, Indonesia
  • SITI MORIN SINAGA Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Universitas Sumatera Utara, Medan, 20155, Indonesia
  • ZUL ALFIAN Department of Chemistry, Faculty of Mathematics and Natural Sciences, Universitas Sumatera Utara, Medan, 20155, Indonesia

Abstract

This study aimed to develop spectrophotometry method by double divisor ratio spectra derivative to determine the levels of dextromethorphan hydrobromide (DEX), doxylamine succinate (DOX) and pseudoephedrine hydrochloride (PSE) in tablet dosage form using ethanol as solvent. The method is based on the use of the coincident spectra of the derivative of the ratio spectra obtained using a double divisor and measuring at the wavelengths selected. Then, the method was applied to determine the levels of DEX, DOX and PSE in tablet dosage form. The selected wavelengths for determination of DEX, DOX and PSE are 277.0 nm, 243.0 nm, and 243.2 nm, respectively. The mean % recoveries were found to be in 100.88%, 100.05%, and 100.26% for DEX, DOX and PSE, respectively. The method is successfully applied to analyze DEX, DOX and PSE in pharmaceutical formulation with no interference from excipients as indicated by the recovery study. All validation parameters were within the acceptable range.

Keywords: Dextromethorphan hydrobromide, Doxylamine succinate, Pseudoephedrine hydrochloride, Spectrophotometry, Double divisor ratio spectra derivative

References

1. Woo T. Pharmacology of cough and cold medicines. J Pediatr Health Care 2008;22:73-9.
2. Government of Indonesia. Indonesian Pharmacopoeia. 5th ed. Jakarta: Indonesian Health Ministry; 2014.
3. Eccless R, Fietze I, Rose UB. Rationale for treatment of common cold and flu with multi-ingredient combination products for multi-symptom relief in adults. Open J Respir Dis 2014;4:73-82.
4. Schoor JV. Colds, flu and coughing: a review of over-the-counter cold and flu medicines. S Afr Fam Pract 2013;55:334-6.
5. Schellack N, Labuschagne Q. Overview and management of colds and flu. S Afr Pharm J 2014;81:19-26.
6. Gelotte CK, Albrecht HH, Hynson J, Gallagher V. A multicenter, randomized, placebo-controlled study of pseudoephedrine for the temporary relief of nasal congestion in children with the common cold. J Clin Pharmacol 2019;59:1573-83.
7. Caglar H, Buyuktuncel E. HPLC method development and validation: simultaneous determination of active ingredients in cough and cold pharmaceuticals. Int J Pharm Pharm Sci 2014;6:421-8.
8. Sirigiri B, Chengalva P, Parameswari SA, Aruna G. A novel HPLC method for the simultaneous determination of chlorpheniramine maleate and dextromethorphan in bulk and pharmaceutical formulation. Int J Pharm Sci Res 2018;9:1147-51.
9. Al-Shaalan NH. Simultaneous determination of chlorphineramine maleate, dextromethorphan HBr and phenylephrin HCl in codilar syrup using high-performance liquid chromatography. J Pharm Sci Innov 2012;1:29-32.
10. Paidipala K, Kamarapu SK. Method development and validation of RP-HPLC method for simultaneous estimation of dextromethorphan hydrobromide, phenylephrine hydrochloride and triprolidine hydrochloride in bulk and combined tablets dosage forms. Int J Pharm Biol Sci 2013;3:172-9.
11. Bhortake PG, Lokhande RS. Simultaneous determination of acetaminophen, phenylephrine hydrochloride and dextromethorphan hydrobromide in liquicap dosage form by RP-HPLC. IJPRR 2014;3:9-14.
12. Mehta PS, Patel VB. RP-HPLC method for simultaneous estimation of bromohexine hydrochloride, dextromethorphan hydrobromide and guaiphenesin in soft gel capsules. Asian J Chem 2013;25:3341-3.
13. Chakraborthy B, Sivasubramanian L, Anusha. Simultaneous estimation of paracetamol, cetrizine and dextromethorphan using second derivative spectrophotometry. Int J Pharm Pharm Sci 2014;6:291-3.
14. Krunali T, Vijya P, Rohit M, Meshram DB. UV spectrophotometric method for estimation of dextromethorphan in bulk and syrup formulation by area under the curve method. Int J Pharm Chem Sci 2013;2:1961-4.
15. Khanvilkar VV, Kothekar RR. Development and validation of simple UV spectrophotometric method for the estimation of dextromethorphan hydrobromide in bulk and marketed dosage formulations. Int J Pharm Sci Drug Res 2016;8:170-3.
16. Gandhi SV, Dyandyan SK. Development and validation of stability-indicating HPTLC method for estimation of dextromethorphan hydrobromide. J Appl Pharm Res 2017;5:27–33.
17. Kumar BP, Vidyadhara S, Murthy TEGK, Sasidhar RLC, Krishna VS. Development and validation of RP-HPLC method for simultaneous estimation of doxylamine succinate and pyridoxine hydrochloride in bulk and pharmaceutical dosage forms. Eurasian J Anal Chem 2017;12:459-68.
18. Richards P, Kumar VK. A new RP-HPLC method develop a new RP-HPLC method development and validation for simultaneous estimation of pyridoxine hydrochloride and doxylamine succinate in bulk drug and pharmaceutical tablet dosage form. IOSR J Pharm Biol Sci 2017;12:74-9.
19. Rosa PCP, Jardim ICSF. Simultaneous determination of clobutinol hydrochloride and doxylamine succinate from syrups by RP HPLC using a new stationary phase containing embedded urea polar groups. Braz J Pharm Sci 2012;48:315-23.
20. Kasturi AK, Medicherla KR, Yaganti R, Balakrishnan N. Second derivative spectrophotometric method for simultaneous determination of doxylamine succinate and pyridoxine HCl in pharmaceutical formulations. Int J Life Sci Pharma Res 2019;9:10-5.
21. Premkumara S, Karunakaran A, Murugesan V, Munusamy J, Jayaprakash R, Murugesan R. Validated uv-spectrophotometric method for the simultaneous estimation of pyridoxine hydrochloride and doxylamine succinate in bulk and in the pharmaceutical dosage form. Adv J Chem A 2019;2:245-55.
22. Nayak SC, Kulkarni PV, Bhaskar V, Chavhan V. Development and validation of UV spectrophotometric method for simultaneous estimation of doxylamine succinate and pyridoxine hydrochloride in bulk and tablet dosage form. Int J Pharm Pharm Sci 2013;5:390-3.
23. Rawool ND, Venkatchalam A, Singh KH. Development and validation of a rapid RP-HPLC method for the simultaneous estimation of cetrizine and pseudoephedrine in pharmaceutical dosage forms. Int J Curr Pharm Res 2013;5:54-60.
24. Balamurugan K, Gokulakrishnan K. Spectrophotometric method for the determination of pseudoephedrine in bulk and formulations. Anal Chem Ind J 2011;10:390-3.
25. Souri E, Rahimi A, Ravari NS, Tehrani MB. Development of a rapid derivative spectrophotometric method for simultaneous determination of acetaminophen, diphenhydramine and pseudoephedrine in tablets. Iran J Pharm Res 2015;14:435-42.
26. Reid IOA, Widaa TA. Spectrophotometric method for the simultaneous determination of pseudoephedrine and triprolidine in bulk and tablet forms. IJAPA 2017;7:21-3.
27. El-Kommos ME, El-Gizawy SM, Atia NN, Hosny NM. Thin-layer chromatography–densitometric determination of some non-sedating antihistamines in combination with pseudoephedrine or acetaminophen in synthetic mixtures and in pharmaceutical formulations. Biomed Chromatogr 2014;28:391-400.
28. Rafat MN, Mahmoud MI, Alaa AS, Nahed TS. Double divisor means centering of ratio spectra as a developed spectrophotometric method for the analysis of five-component. J Saudi Chem Soc 2017;21:S283-S92.
29. Gohel RV, Parmar SJ, Patel BA. Development and validation of double divisor-ratio spectra derivative spectrophotometric method for simultaneous estimation of olmesartan medoxomil, amlodipine besylate and hydrochlorthiazide in tablet dosage form. Int J PharmTech Res 2014;6:1518-25.
30. Abdelwahab NS, Abdelaleem EA. Application of fourier function to double divisor ratio spectra curves for analysis of some amoebicide drugs in their ternary mixtures. Pharm Anal Acta 2012;3:1-7.
31. Ermer J, Miller JH. Method validation in pharmaceutical analysis. A guide to best practice. Weinheim: Wiley-Vch Verlag GmBH and Co. KGaA; 2005.
32. Sowjanya G, Ganapaty S, Almas S. Derivative UV spectroscopic approaches in multicomponent analysis–a review. Int J Pharm Pharm Sci 2019;11:1-11.
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TARIGAN, R. E., MUCHLISYAM, SINAGA, S. M., & ALFIAN, Z. (2020). DEVELOPMENT AND VALIDATION OF DOUBLE DIVISOR RATIO SPECTRA DERIVATIVE SPECTROPHOTOMETRY METHOD FOR TERNARY MIXTURE OF DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PSEUDOEPHEDRINE HYDROCHLORIDE IN TABLET DOSAGE FORM. International Journal of Applied Pharmaceutics, 12(6), 249-252. https://doi.org/10.22159/ijap.2020v12i6.39037
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