APPLICATION MEAN CENTERING RATIO SPECTRA METHOD FOR TERNARY MIXTURE OF DEXTROMETHORPHAN HBr, DOXYLAMINE SUCCINATE, AND PSEUDOEPHEDRINE HCl IN TABLET PREPARATIONS

RIDA EVALINA TARIGAN; HENDRI FAISAL; IMAN KRISTIAN LASE; SAFURA PUTRI HAFIFAH

doi:10.22159/ijap.2024v16i4.50299

Authors

RIDA EVALINA TARIGAN Departement of Pharmaceutical Chemistry, Faculty of Pharmacy and Health, Institut Kesehatan Helvetia, Medan, Sumatera Utara-20124, Indonesia https://orcid.org/0000-0002-1151-8038
HENDRI FAISAL Departement of Pharmaceutical Chemistry, Faculty of Pharmacy and Health, Institut Kesehatan Helvetia, Medan, Sumatera Utara-20124, Indonesia https://orcid.org/0000-0002-8452-0796
IMAN KRISTIAN LASE Departement of Pharmaceutical Chemistry, Faculty of Pharmacy and Health, Institut Kesehatan Helvetia, Medan, Sumatera Utara-20124, Indonesia https://orcid.org/0000-0002-1151-8038
SAFURA PUTRI HAFIFAH Departement of Pharmaceutical Chemistry, Faculty of Pharmacy and Health, Institut Kesehatan Helvetia, Medan, Sumatera Utara-20124, Indonesia https://orcid.org/0000-0002-1151-8038

DOI:

https://doi.org/10.22159/ijap.2024v16i4.50299

Keywords:

Mean centering ratio spectra, Ternary mixtures, Dextromethorphan HBr, Doxylamine succinate, Pseudoephedrine HCl

Abstract

Objective: The aim of this research is to apply the Mean Centering Ratio Spectra (MCRS) method for a ternary mixture of Dextromethorphan Hydrobromide (DE), Doxylamine Succinate (DO), and Pseudoephedrine Hydrochloride (PS) in tablet preparations.

Methods: The absorption spectra of DE (40-430 μg/mL), DO (20-430 μg/mL), and PS (230-630 μg/mL) were scanned in the 200-400 nm range. DE determination involved dividing DE spectra by PS (430 μg/mL) and mean-centered the ratio spectra. DO spectra were divided by DE (40 μg/mL) to obtain mean-centered ratio spectra. The mean-centered ratio spectra for PS were obtained by dividing the scanned spectra of its prepared solutions by the standard spectrum of DE, which had a concentration of 70 μg/mL.

Results: Method validation parameters, including linearity, accuracy, precision, Limit of Detection (LOD), and Limit of Quantification (LOQ), were assessed. The results indicated linearity values of 0.9988, 0.9992, and 0.9998, respectively, for DE, DO, and PS. Accuracy: 99.84%, 100.15%, and 100.33%, respectively, for DE, DO, and PS. Precision: 0.53%, 0.54%, and 0.74%, respectively, for DE, DO, and PS. LOD: 1.85 μg/mL, 2.09 μg/mL, and 1.56 μg/mL, respectively, for DE, DO, and PS. LOQ: 6.19 μg/mL, 6.97 μg/mL, and 5.22 μg/mL, respectively, for DE, DO, and PS. All validation method parameters meet International Conference of Harmonization (ICH) validation requirements.

Conclusion: The MCRS method can be applied for the simultaneous ternary mixtures of DE, DO, and PS in tablet preparations. Its successful application, combined with rigorous validation results, suggests its potential for adoption in routine pharmaceutical analysis, contributing to the advancement of quality control practices in the industry.

Downloads

Download data is not yet available.

References

Saad AS, Naguib IA, Draz ME, Zaazaa HE, Lashien AS. Validated analytical methods for the determination of drugs used in the treatment of hyperemesis gravidarum in multiple formulations. J AOAC Int. 2018;101(2):427-436. doi: 10.5740/jaoacint.17-0069.

Attimarad M, Venugopala KN, Chohan MS, David M, Molina EIP, Sreeharsha N, Nair AB, Tratrat C, Altaysan AI, Balgoname AA. An experimental design approach to quantitative expression for quality control of a multicomponent antidiabetic formulation by the hilic method. Molecules. 2022;27(10):3135. doi: 10.3390/molecules27103135.

Tarigan RE, Muchlisyam, Sinaga SM, Alfian Z. 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. Int J App Pharm. 2020;12(6):249-252. doi:10.22159/ijap.2020v12i6.39037.

Kelani KM, Gad AG, Fayez YM, Mahmoud AM, Abdel-Raoof AM. Three developed spectrophotometric methods for determination of a mixture of ofloxacin and ornidazole; application of greenness assessment tools. BMC Chem. 2023;17(1):16. doi:10.1186/s13065-023-00932-3.

Tarigan RE, Muchlisyam, Sinaga SM, Alfian Z. Simultaneous determination of dextromethorphan hydrobromide, doxylamine succinate and pseudoephedrine hydrochloride in cough and cold syrup by area under curve spectrophotometry method. Rasayan J Chem. 2021;14(1):629-634. doi:10.31788/ RJC.2021.1416068.

Alsamarrai KF, Ameen ST. Simultaneous ratio derivative spectrophotometric determination of paracetamol, caffeine and ibuprofen in their ternary form. Baghdad Sci J. 2022;19(6):1276-1285. doi:10.21123/bsj.2022.6422.

Tran BT, Tran TN, Tran AMT, Nguyen GCD, Nguyen QTT. Simultaneous determination of paracetamol, ibuprofen, and caffeine in tablets by molecular absorption spectroscopy combined with classical least square method. Molecules. 2022;27(9):2657. doi: 10.3390/molecules27092657.

Tarigan RE, Silitonga AS, Sari M, Nadia S. Development and validation of mean centering ratio spectra spectrophotometry method for binary mixture of glimepiride and metformin hydrochloride in tablet disage form. AIP Conf Proc.2023;2626 (1):150005. doi:10.1063/5.0136130.

Muchlisyam, Sudarmi, Caroline C. Mean centering of ratio spectra method for the analysis of theophylline and ephedrine hcl mixture in tablet. Asian J Pharm Clin Res. 2018;11(5):218–223. doi:10.22159/ajpcr.2018.v11i5.24365.

Ali N, Hegazy M, Abdelkawy M, Abdelaleem E. Simultaneous determination of methocarbamol and ibuprofen or diclofenac potassium using mean centering of the ratio spectra method. Acta Pharm. 2012;62(2):191-200. doi:10.2478/v10007-012-0016-z.

Abdelrahman MM, Abdelaleem EA. Mean centering of ratio spectra and successive derivative ratio spectrophotometric methods for determination of isopropamide iodide, trifluoperazine hydrochloride and trifluoperazine oxidative degradate. J Saudi Chem Soc. 2016;20:S153–S160. doi:10.1016/j.jscs.2012.10.003.

El-Maraghy CM, Lamie NT. Three smart spectrophotometric methods for resolution of severely overlapped binary mixture of Ibuprofen and Paracetamol in pharmaceutical dosage form. BMC Chem. 2019;13(1):99. doi: 10.1186/s13065-019-0618-3.

Rizk MS, Sultan M, Talaat NM, Youssef NF. Manipulating mean centering of ratio and first derivative of ratio spectra methods for simultaneous determination of formoterol fumarate and budesonide in drug substances and combined pressurized metered dose inhaler. Anal Chem Lett. 2018;8(5):692–703. doi:10.1080/22297928.2018.1465469.

Yehia AM, El-ghobashy MR, Helmy AH, Youssef NF. Stability testing followed by manipulating mean centering ratio and derivative ratio spectrophotometric methods for the determination of gliquidone in presence of its induced degradation products. Anal Chem Lett. 2018;8(3):348–360. doi: 10.1080/22297928.2018.1439402.

Zarei AR, Mardi K. Development of spectrophotometric method for simultaneous determination of copper β-resorcylate, lead β-resorcylate and lead oxide in double base solid propellants using mean centering of ratio spectra technique. J Iran Chem Soc. 2022;19(8):3347–3356. doi: 10.1007/s13738-022-02527-6.

Adriani F, Bachri M, Sinaga SM. Development and validation of double divisor ratio spectra derivative spectrophotometry method for ternary mixture of guaifenesin, dextromethorphan hbr, and diphenhydramine hcl in tablet dosage form. Asian J Pharm Clin Res. 2016;11(13):1-3. doi: 10.22159/ajpcr.2018.v11s1.26550

Ali MS, Elsaman T. Development and validation of the uv spectrophotometric method for simultaneous determination of paracetamol and pseudoephedrine in bulk and combined tablet dosage form. Pharm Chem J. 2021;54(12):1306–1310. doi: 10.1007/s11094-021-02360-w.

Caglar H, Buyuktuncel E. Hplc method development and validation simultaneous determination of active ingredients in cough and cold pharmaceuticals. Int J Pharm Sci. 2014;6(10):421-428.

Reid IOA, Kariem EAG. Development and validation of a hplc method for the simultaneous determination of pseudoephedrine, dextromethorphan, and triprolidine in their combined cough and cold syrups. JAC. 2017;13(11):6011-6017. doi: 10.24297/jac.v13i11.5911.

Harde MT, Lakade SH. A stability-indicating hplc method for estimation of doxylamine succinate in tablets and characterization of its major alkaline stress degradation product. Future J Pharm Sci. 2021;7(1). doi: 10.1186/s43094-021-00276-6.

Gandhi SV, Dyandyan SK. Development and validation of stability indicating hptlc method for estimation of dextromethorphan hydrobromide. J App Pharm Res. 2017;5(3):27-33. doi: 10.18231/2348-0335.2017.0004.

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(3):391-400. doi:10.1002/bmc.3033.

Ahmar H, Fakhari AR. Electro-oxidation and adsorptive stripping voltammetric determination of ephedrine and pseudoephedrine at carboxylated multi-walled carbon nanotube-modified electrode. Anal Methods. 2012;4(3):812. doi:10.1039/c2ay05680a.

Tarigan RE, Sianturi DM, Nadya S. Determination of pseudoephedrine hydrochloride and triprolidine hydrochloride simultaneously by using area under curve spectrophotometry ultraviolet. Rasayan J Chem. 2023;16(01):223–226. doi: 10.31788/rjc.2023.1618072.

Chaudhry H, Rangra NK. Development and validation of a stability indicating green analytical method for the simultaneous estimation of l-glutathione, n-acetyl l-cysteine and vitamin c in marketed formulation using uv–visible spectroscopy. Future J Pharm Sci. 2023;9(1). doi: 10.1186/s43094-023-00523-y.

Ghonim R, Tolba MM, Ibrahim F, El-Awady MI. Smart green spectrophotometric assay of the ternary mixture of drotaverine, caffeine and paracetamol in their pharmaceutical dosage form. BMC Chemistry. 2023;17(181):1-21. doi: 10.1186/s13065-023-01097-9.

Ghany MFA, Aziz OA, Ayad MF, Mikawy NN. Simultaneous determination of octinoxate, oxybenzone, and octocrylene in a sunscreen formulation using validated spectrophotometric and chemometric methods. J AOAC Int. 2015;98(5):1215–1225. doi: 10.5740/jaoacint.14-229.

Omer SA, Fakhre NA. Simultaneous determination of ternary mixture of carboxin, chlorpyrifos, and tebuconazole residues in cabbage samples using three spectrophotometric methods. J Anal Methods in Chem. 2020;1-16. doi: 10.1155/2020/4912762.

Anwar M, Kormod L, Kessiba A, Abbas S, El-Gendy A. Development and validation of spectrophotometric methods for the simultaneous determination of brimonidine tartrate and timolol maleate in bulk and ophthalmic preparations. Rec Pharm and Biomedical Sci. 2023;7(1):97-114. doi:10.21608/rpbs.2023.182443.1198.

Bachri M, Sitohang E. Simultaneous assay of metformin and glibenclamide in combined dosage form by mean centered of spectra ratio methods. Rasayan J Chem. 2019;12(03):1509–1517. doi:10.31788/rjc.2019.1235208.

Mostafa NM, Elsayed GM, Hassan NY, El Mously DA. Development and validation of eco-friendly liquid chromatographic and spectrophotometric methods for simultaneous determination of coformulated drugs: phenylephrine hydrochloride and prednisolone acetate. J AOAC Int. 2017;100(6):1761-1770. doi:10.5740/jaoacint.17-0001.

Hegazy MAM, Fayez YM. Mean centering of ratio spectra and concentration augmented classical least squares in a comparative approach for quantitation of spectrally overlapped bands of antihypertensives in formulations. Spectrochim Acta A Mol Biomol Spectrosc. 2015;140:210-215. doi:10.1016/j.saa.2014.12.103.

Government of Indonesia. Indonesian Pharmacopoeia. 6th ed. Jakarta: Indonesian Health Ministry; 2020.