QUANTITATIVE ANALYSIS OF DEXTROMETHORPHAN-HBr, GUAIFENESIN, AND DIPHENHYDRAMINE-HCl IN TABLET DOSAGE FORM BY RATIO DIFFERENCE SPECTROPHOTOMETRY METHOD

RIDA EVALINA TARIGAN; MUHAMMAD ANDRY; ANNISA TIFANY ZULMI MARPAUNG; MUHAMMAD AMIN NASUTION; MUHAMMAD FAUZAN LUBIS

doi:10.22159/ijap.2024v16i1.49218

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
MUHAMMAD ANDRY Departement of Pharmaceutical Chemistry, Faculty of Pharmacy and Health, Institut Kesehatan Helvetia, Medan, Sumatera Utara-20124, Indonesia
ANNISA TIFANY ZULMI MARPAUNG Departement of Pharmaceutical Chemistry, Faculty of Pharmacy and Health, Institut Kesehatan Helvetia, Medan, Sumatera Utara-20124, Indonesia
MUHAMMAD AMIN NASUTION Faculty of Pharmacy, Universitas Muslim Nusantara Al Washliyah, Medan, Sumatera Utara-20147, Indonesia https://orcid.org/0000-0003-0753-776X
MUHAMMAD FAUZAN LUBIS Department of Pharmaceutical Biology, Faculty of Pharmacy, Universitas Sumatera Utara, Medan, Indonesia

DOI:

https://doi.org/10.22159/ijap.2024v16i1.49218

Keywords:

Dextromethorphan HBr, Guaifenesin, Diphenhydramine HCl, Spectrophotometry, Ratio difference

Abstract

Objective: This study aims to develop a spectrophotometric method with the Ratio Difference method using ethanol pro analysis solvent to obtain the results of Dextromethorphan Hydrobromide (HBr) levels of Guaifenesin and Diphenhydramine Hydrochloride (HCl) in tablets.

Methods: The Ratio Difference Sprctrophotography method involves dividing the mixture spectrum by the standard spectrum of each analyte and reducing the ratio to obtain a spectrum that does not depend on the concentration of the analyte used as a divider and can directly determine the levels of Dextromethorphan HBr, Guaifenesin, and Diphenhydramine HCl in the range 200-400 nm wavelength using experimentally calculated absorbance.

Results: The maximum wavelengths of Dextromethorphan HBr, Guaifenesin, and Diphenhydramine HCl were obtained at 278 nm, 273 nm, and 252 nm, respectively. The average % accuracy obtained was 99.60% for Dextromethorphan HBr, 98.98% for Guaifenesin, and 100.32% for Diphenhydramine HCl in dosage forms.

Conclusion: This method was successfully applied with simultaneous estimation to determine Dextromethorphan HBr, Guaifenesin, and Diphenhydramine HCl levels in tablet preparations and met the validation requirements.

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References

Gamil AM, Hamad MA. Validation of hplc method for simultaneous determination of pseudoephedrine HCL, guaifenesin, chlorpheniramine maleate and dextromethorphan HBR. Univ J Pharm Res. 2020;5(5)448. doi: 10.22270/ujpr.v5i5.488.

Merey HA, Ramadan NK, Diab SS, Moustafa AA. Validated UPLC method for the determination of guaiphenesin, oxeladin citrate, diphenhydramine, and sodium benzoate in their quaternary mixture used in the treatment of cough, in the presence of guaiphenesin-related substance (guaiacol). Chem Pap. 2018;72(9):2247-54. doi: 10.1007/s11696-018-0454-2.

Itagimatha N, Manjunatha DH. RP-HPLC-UV method development and validation for simultaneous determination of terbutaline sulphate, ambroxol HCl and guaifenesin in pure and dosage forms. Ann Pharm Fr. 2019;77(4):295-301. doi: 10.1016/j.pharma.2019.02.004, PMID 31027752.

Wibowo A, Kerja M. Obat anti Batuk mechanism of action of anti-cough medicine. JK Unila. 2021;5(1):75-83.

Imani LN, Lestari K, Mulyaningsih W. Kajian farmasi klinis penggunaan obat batuk ”X” dengan kandungan Bromheksin HCl untuk pengencer dahak pada anak. J Pharm Sci. 2023;6(1):315-21. doi: 10.36490/journal-jps.com.v6i1.69.

Palur K, Archakam SC, Koganti B. Chemometric assisted UV spectrophotometric and RP-HPLC methods for simultaneous determination of paracetamol, diphenhydramine, caffeine and phenylephrine in tablet dosage form. Spectrochim Acta A Mol Biomol Spectrosc. 2020;243:118801. doi: 10.1016/j.saa.2020.118801, PMID 32827914.

Huang SJ, Kannaiyan S, Venkatesh K, Cheemalapati S, Haidyrah AS, Ramaraj SK. Synthesis and fabrication of Ni-SiO2 nanosphere-decorated multilayer graphene nanosheets composite electrode for highly sensitive amperometric determination of guaifenesin drug. Microchem J. 2021;167:106325. doi: 10.1016/j.microc.2021.106325.

Mohamed D, Hegazy MA, El-Sayed GM, Youssef SH. Greenness evaluation of different chromatographic approaches for the determination of dextromethorphan, phenylephrine and brompheniramine in their pharmaceutical formulation. Microchem J. 2020;157:104893. doi: 10.1016/j.microc.2020.104893.

Tarigan RE, Muchlisyam SSM, Sinaga SM, Alfian Z. Development and validation of area under curve spectrophotometry method for ternary mixture of dextromethorphan HBr, doxylamine succinate and pseudoephedrine HCl in tablet dosage form. AIP Conf Proc. 2021;2342(6):6-9. doi: 10.1063/5.0045551.

Benni I, Iga S. Uji Sifat fisik tablet salut enterik kalium diklofenak. J Penelit. Farmaco Indones. 2019;8(1):12-7. doi: 10.51887/jpfi.v8i1.588.

Bachri M, Permata YM, Syahputra H. PLS calculation of FTIR and spectrophotometric methods for determination simultaneous of dextromethorphan HBr and glyceryl guaiacolate in tablet mixture. Rasayan J Chem. 2022;15(1):143-9. doi: 10.31788/RJC.2022.1516510.

Cheng Y, Qin H, Acevedo NC, Jiang X, Shi X. 3D printing of extended-release tablets of theophylline using hydroxypropyl methylcellulose (HPMC) hydrogels. Int J Pharm. 2020;591:119983. doi: 10.1016/j.ijpharm.2020.119983, PMID 33065220.

Chaudhari K, Wang J, Xu Y, Winters A, Wang L, Dong X. Determination of metformin bio-distribution by LC-MS/MS in mice treated with a clinically relevant paradigm. Plos One. 2020;15(6):e0234571. doi: 10.1371/journal.pone.0234571, PMID 32525922.

Zilhadia Z, Supandi S, Alfarisi S. Simultaneous determination of metformin and glimepiride in fixed-dose combination tablets sold in Pramuka market using validated UV spectrophotometric method. J Sains Farm Klin. 2021;8(3):303. doi: 10.25077/jsfk.8.3.303-308.2021.

Abafe OA, Spath J, Fick J, Jansson S, Buckley C, Stark A. LC-MS/MS determination of antiretroviral drugs in influents and effluents from wastewater treatment plants in KwaZulu-Natal, South Africa. Chemosphere. 2018;200:660-70. doi: 10.1016/j.chemosphere.2018.02.105, PMID 29524887.

Tarigan RE, Sarumaha Y. Determination of isoniazid and pyridoxine hydrochloride levels in tablets with ultraviolet spectrophotometry by successive ratio derivative. Int Arch Sci Public Heal. 2022;3(1):95-101.

Wozniak MK, Wiergowski M, Aszyk J, Kubica P, Namiesnik J, Biziuk M. Application of gas-chromatography–tandem mass spectrometry for the determination of amphetamine-type stimulants in blood and urine. J Pharm Biomed Anal. 2018;148:58-64. doi: 10.1016/j.jpba.2017.09.020, PMID 28957720.

Buchalter S, Marginean I, Yohannan J, Lurie IS. Gas chromatography with tandem cold electron ionization mass spectrometric detection and vacuum ultraviolet detection for the comprehensive analysis of fentanyl analogues. J Chromatogr A. 2019;1596:183-93. doi: 10.1016/j.chroma.2019.03.011, PMID 30876740.

Nezhadali A, Shapouri MR, Amoli Diva M, Hooshangi AH, Khodayari F. Method development for simultaneous determination of active ingredients in cough and cold pharmaceuticals by high-performance liquid chromatography. Heliyon. 2019;5(12):e02871. doi: 10.1016/j.heliyon.2019.e02871, PMID 31872108.

Lotfy HM, Ahmed DA, Abdel Rahman MK, Weshahy SAF. Study of efficiency and spectral resolution for mathematical filtration technique using novel unlimited derivative ratio and classical univariate spectrophotometric methods for the multicomponent determination-stability analysis. Heliyon. 2019;5(5):e01669. doi: 10.1016/j.heliyon.2019.e01669, PMID 31193052.

Abdelaleem EA, Abdelwahab NS. Green chromatographic method for analysis of some anti-cough drugs and their toxic impurities with comparison to conventional methods. Saudi Pharm J. 2018;26(8):1185-91. doi: 10.1016/j.jsps.2018.07.007, PMID 30532640.

Alam P, Ezzeldin E, Iqbal M, Mostafa GAE, Anwer MK, Alqarni MH. Determination of delafloxacin in pharmaceutical formulations using a green RP-HPTLC and NP-HPTLC methods: a comparative study. Antibiotics (Basel). 2020;9(6):1-14. doi: 10.3390/antibiotics9060359, PMID 32630451.

Voltammetric SW. Selective I. Anal Square Wave Voltammetric Ion Sel. 2022;14(6):621-37.

Fan Z, Chang Y, Cui C, Sun L, Wang DH, Pan Z. Near-infrared fluorescent peptide nanoparticles for enhancing esophageal cancer therapeutic efficacy. Nat Commun. 2018;9(1):2605. doi: 10.1038/s41467-018-04763-y, PMID 29973582.

Atole DM, Rajput HH. Ultraviolet spectroscopy and its pharmaceutical applications-a brief review. Asian J Pharm Clin Res. 2018;11(2):59-66. doi: 10.22159/ajpcr.2018.v11i2.21361.

Yildiz T, Gu R, Zauscher S, Betancourt T. Doxorubicin-loaded protease-activated near-infrared fluorescent polymeric nanoparticles for imaging and therapy of cancer. Int J Nanomedicine. 2018;13:6961-86. doi: 10.2147/IJN.S174068, PMID 30464453.

Gadhari NS, Gholave JV, Patil SS, Patil VR, Upadhyay SS. Enantioselective high-performance new solid contact ion-selective electrode potentiometric sensor based on sulphated γ-cyclodextrin carbon nanofiber composite for determination of multichiral drug moxifloxacin. J Electroanal Chem. 2021;882:114981. doi: 10.1016/j.jelechem.2021.114981.

Proma Mukherjee, Debarupa Dutta Chakraborty, Prithviraj Chakraborty, Bhupendra Shrestha, Bhuyan NR. Different ultraviolet spectroscopic methods: a retrospective study on its application from the viewpoint of analytical chemistry. Asian J Pharm Clin Res 2021;14(9):1-11. doi: 10.22159/ajpcr.2021.v14i9.42172.

Emam AA, Abdelaleem EA, Naguib IA, Abdallah FF, Ali NW. Successive ratio subtraction as a novel manipulation of ratio spectra for the quantitative determination of a mixture of furosemide, spironolactone and canrenone. Spectrochim Acta A Mol Biomol Spectrosc. 2018;192:427-36. doi: 10.1016/j.saa.2017.11.034, PMID 29202387.

Bachri M. Simultaneous assays of metformin HCl and glibenclamide mixture using two analytical methods of spectrophotometry. Int J App Pharm. 2019;11(6):139-46. doi: 10.22159/ijap.2019v11i6.34022.

Tarigan RE, Muchlisyam SSM, Sinaga SM, Alfian Z. Development and validation of area under curve spectrophotometry method for ternary mixture of dextromethorphan HBr, doxylamine succinate and pseudoephedrine HCl in tablet dosage form. AIP Conf Proc. 2021;2342(6):1-4. doi: 10.1063/5.0045551.

Bachri M, Reveny J, Metri Permata YM, Situmorang CEA. Validation of intersection absorption spectrum for simultaneous determination of betamethasone valerate and neomycin sulfate in cream. Rasayan J Chem. 2019;12(1):232-9. doi: 10.31788/RJC.2019.1215013.

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(3):1509-17. doi: 10.31788/RJC.2019.1235208.

Mansour FR. A new innovative spectrophotometric method for the simultaneous determination of sofosbuvir and ledipasvir. Spectrochim Acta A Mol Biomol Spectrosc. 2018;188:626-32. doi: 10.1016/j.saa.2017.07.066, PMID 28783604.

Sinaga SM, Pertiwi NN, Muchlisyam. Quantitative analysis of amlodipine besylate and valsartan in tablet dosage form by absorption factor spectrophotometry method. Rasayan J Chem. 2022;15(2):1386-9. doi: 10.31788/RJC.2022.1526611.

Gamil AM, Hamad MA. Validation of hplc method for simultaneous determination of pseudoephedrine HCL, guaifenesin, chlorpheniramine maleate and dextromethorphan HBr. Univ J Pharm Res. 2020;5(5):448. doi: 10.22270/ujpr.v5i5.488.

Anunthawan T, Rimlumduan T. Antioxidant activity, anti-tyrosinase activity, and lipstick pigments of Oryza sativa Linn. and carissa carandas linn. extracts. J Appl Pharm Sci. 2023;13:1-8. doi: 10.7324/JAPS.2023.145623.

Sen AK, Ghodasara S, Sen DB, Maheshwari RA, Zanwar AS, Dumpala RL. Evaluation of remogliflozin, vildagliptin, and metformin in tablet dosage form using modern and cost-effective UV spectroscopic methods. J Appl Pharm Sci. 2023;13(09):121-32. doi: 10.7324/JAPS.2023.136050.