A COMPREHENSIV REVIEW ON ANALYTICAL METHODS FOR ESTIMATION OF DEXTROMETHORPHAN AND SITAGLIPTIN
Main Article Content
Keywords
DeXtroMethorphan HydroBromide; Sitagliptin Phosphate; Analytical method development; HPLC; UV HPLC; RP-HPLC; HPTLC; Drug profile; Pharmacopeial Methods.
Abstract
Dextromethorphan Hydrobromide is a non-selective serotonin uptake inhibitor and an agonist of sigma-1 receptor, and acts centrally to elevate threshold for coughing. Sitagliptin, the dipeptidyl peptidase-4 (DPP-4) inhibitor, is used to treat type 2 diabetes. Their physicochemical characteristics, modes of action, and clinical significance are all thoroughly covered in this review. For the evaluation of both medications separately and in combination with other agents, it also provides a summary of official pharmacopeial procedures and reported analytical techniques, such as HPLC, RP-HPLC, HPTLC, Spectrophotometry, and Micellar Liquid Chromatography. The progress and difficulties in method development and validation are highlighted by a critical assessment of chromatographic parameters, detection wavelengths, and mobile phases. This review provides a comprehensive reference for researchers and analysts working on dextromethorphan and sitagliptin, highlighting the importance of reliable, sensitive, and stability-indicating techniques for routine quality control and pharmacokinetic investigations.
References
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15. Marín A., García E., García A., Barbas C., “Validation of a HPLC quantification of acetaminophen, phenylephrine, and chlorpheniramine in pharmaceutical formulations: capsules and sachets.” J Pharm Biomed Anal. 2004; 36(5): 1031–1036.
16. Dai Z., Rao R., Zhou E., Li K., Li W., “A novel and simple LC MS/MS quantitative method for dextromethorphan and dextrorphan in oral fluid.” J Anal Toxicol. 2019; 43(2); 137–145.
17. Galli V., Barbas C., “High-performance liquid chromatographic analysis of dextromethorphan, guaifenesin, and benzoate in a cough syrup for stability testing.” J Chromatogr A. 2004; 1048(2): 207–211.
18. Ashraf M., Shahzad MN, Hayat MM, Rahman J., Ejaz S., Altaf H., “Development and validation of an HPLC method for the quantification of sitagliptin in plasma and tablet dosage form.” Lat Am J Pharm. 2015; 34(3): 456–461.
19. T. V. Raghava Raju, N. Anil Kumar, S. Raja Kumar, A. Malleswara Reddy, N. Someswara Rao, I. Mrutyunjaya Rao, “Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Guaifenesin and Dextromethorphan Impurities in Pharmaceutical Formulations, Chromatogr.” Res. Int. 1–12.
20. Shah PA, Shah JV, Sanyal M., Shrivastav PS., “LC-tandem mass spectrometry method for the simultaneous determination of metformin and sitagliptin in human plasma after ion-pair solid phase extraction.” J Pharm Biomed Anal. 2016; 131: 64–70.
21. Vineeta V., Rupali R., “Development and Validation of Simple UV Spectrophotometric Method for the Estimation of Dextromethorphan Hydrobromide in Bulk and Marketed Dosage Formulations” International Journal of Pharmaceutical Sciences and Drug Research 2016; 8(3): 170-173
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23. J. Dahiya, A. Singh, S. Kumar Gupta, B. Kumar, “Spectrophotometric Estimation of Dextromethorphan in Bulk Drug using Hydrotropic Solubilization Technique” Asian J. Pharm. Ana. 3; 90–93.
24. T. V. Raghava Raju, N. Anil Kumar, S. Raja Kumar, A. Malleswara Reddy, N. Someswara Rao, I. Mrutyunjaya Rao., “Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Guaifenesin and Dextromethorphan Impurities in Pharmaceutical Formulations” Chromatogr. Res. Int. 2013; 1–12.
25. D. Varasala, S.K. Konidala, “Stability-indicating RP-HPLC method development & validation for simultaneous determination of doxylamine succinate and dextromethorphan hydrobromide in pharmaceutical dosage forms” Der Pharm. Lett. 2015; 7;112–118.
26. P. Amaratunga, M. Clothier, B.L. Lemberg, D. Lemberg, “Determination of dextromethorphan in oral fluid by LC-MS-MS” J. Anal. Toxicol. 2016; 40; 360–366.
27. K. Souza Seba, V. Berg Cattani, J.C. Saraiva Gonçalves, R. Vianna-Jorge, R.D.C. Elias Estrela, “A novel and simple LCMS/MS quantitative method for dextromethorphan and dextrorphan in oral fluid, Bioanalysis.” 2019; 11; 913-922.
28. S.K. Gandhi, Santosh V., Dyandyan., “Development and validation of stability indicating HPTLC method for estimation of dextromethorphan hydrobromide” J. Appl. Pharm. Res. 2019; 5; 27–33.
29. K. Bhavya Sri, G. Sri vani Shailaja, Narmada Valla Keerthi., “Development and validation of UV spectrophotometric method for simultaneous estimation of Sitagliptin and Metformin in bulk and combined pharmaceutical formulation” International Journal of Current Pharmaceutical Research, 2022; 14(2); 65-68.
30. Pathade A., Imran M., Bairagi V., Ahire Y., “Development and Validation of Stability Indicating UV Spectrophotometric Method for the Estimation of Sitagliptin Phosphate in Bulk and Tablet Dosage Form.” Journal of Pharmacy Research. 2011: 4(3); 871-873.
31. R. Lavanya, Md. Yunoos, “Development and Validation of RP-HPLC method for the estimation of Sitagliptin Phosphate in Bulk and its Tablet Dosage Form” Journal of advanced pharmacy education and research, 2013; 3(4); 475-479.
32. T. Raja and A. Lakshmana Rao. “Validated HPTLC method for simultaneous estimation of metformin hydrochloride and sitagliptin phosphate in bulk drug and formulation” Rasāyan J. Chem, 2012; 5(3); 407-413.
33. Sharifa Sultana, Md. Shahadat Hossain, Md. Samiul Islam and Abu Shara Shamsur Rouf, “Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique” Dhaka Univ. J. Pharm. Sci, 2018; 17(1); 123-129.
34. Suleman S. Khoja and Laxman J. Patel, “Development and Validation of New Analytical LCMS/MS Method for the Estimation of Antidiabetic Drugs Ertugliflozin and Sitagliptin in Combined Pharmaceutical Dosage form” Journal of Pharmaceutical Research International, 2021; 33(30A); 194-204.
35. Mohamed Salim, Nahed El-Enany, Fathallah Belal, Mohamed Walash, “Simultaneous Determination of Sitagliptin and Metformin in Pharmaceutical Preparations by Capillary Zone Electrophoresis and its Application to Human Plasma Analysis,” Analytical Chemistry Insights, 2012; 7; 31–46.
2. Rang H.P., Ritter J. M., Flower R. J., Henderson G., Rang & Dale ‘s Pharmacology, 8, Elsevier Churchill Livingstone, 2016, 353-520.
3. Raynolds S. M., Mackenzie A. J., Spina D., Page C. Trends Pharmacal. Sci., 25, 11, 2004, 569
4. See: (a) www.diabetes.org; (b) http://www.who.int.
5. Adeghate E., Kalasz H., Veress G., and Tekes K., Curr. Med. Chem., 2010, 17, 517–551
6. Adeghate E., Feher E., and Kalasz H., Expert Opin. Invest. Drugs, 2015, 24, 1–15
7. Peng F., Chen Y., Chen C., J. Org. Chem., 2017, 82(17), 9023–9029
8. Weber A., J. Med. Chem., 2004, 48, 4135–4141
9. Bergman A., Ebel D., Liu F., “Absolute bioavailability of sitagliptin, an oral dipeptidyl peptidase-4 inhibitor, in an oral dipeptidyl peptidase-4 inhibitor, in healthy volunteers.” Biopharm Drug Dispos. 2007; 28: 315–322.
10. Herman GA., Stevens C., Van Dyck K., “Pharmacokinetics and pharmacodynamics of sitagliptin, an inhibitor of dipeptidyl peptidase IV, in healthy subjects: results from two randomized, double-blind, placebo-controlled studies with single oral doses.” Clin Pharmacol Ther. 2005; 78: 675–688.
11. Drucker D., Expert Opin. Invest. Drugs, 2003; 12, 87–100
12. SaeRam Oh; Suneil Agrawal., Sarah Sabir., Alan Taylor., National Center for Biotechnology Information. PubChem Compound Summary https://www.ncbi.nlm.nih.gov/books/NBK538216/#article-20426.s3
13. National Center for Biotechnology Information. PubChem Compound Summary https://pubchem.ncbi.nlm.nih.gov/compound/Sitagliptin-Phosphate-Monohydrate
14. Caraballo I., Fernández-Álvarez M., Holgado MA, Álvarez-Fuentes J., Rabasco AM., “Simultaneous HPLC determination of some drugs commonly used in cold medications—Dextromethorphan, diphenhydramine, phenylephrine, phenylpropanolamine, and pseudoephedrine.” Drug Dev Ind Pharm. 1995; 21(5): 605–613.
15. Marín A., García E., García A., Barbas C., “Validation of a HPLC quantification of acetaminophen, phenylephrine, and chlorpheniramine in pharmaceutical formulations: capsules and sachets.” J Pharm Biomed Anal. 2004; 36(5): 1031–1036.
16. Dai Z., Rao R., Zhou E., Li K., Li W., “A novel and simple LC MS/MS quantitative method for dextromethorphan and dextrorphan in oral fluid.” J Anal Toxicol. 2019; 43(2); 137–145.
17. Galli V., Barbas C., “High-performance liquid chromatographic analysis of dextromethorphan, guaifenesin, and benzoate in a cough syrup for stability testing.” J Chromatogr A. 2004; 1048(2): 207–211.
18. Ashraf M., Shahzad MN, Hayat MM, Rahman J., Ejaz S., Altaf H., “Development and validation of an HPLC method for the quantification of sitagliptin in plasma and tablet dosage form.” Lat Am J Pharm. 2015; 34(3): 456–461.
19. T. V. Raghava Raju, N. Anil Kumar, S. Raja Kumar, A. Malleswara Reddy, N. Someswara Rao, I. Mrutyunjaya Rao, “Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Guaifenesin and Dextromethorphan Impurities in Pharmaceutical Formulations, Chromatogr.” Res. Int. 1–12.
20. Shah PA, Shah JV, Sanyal M., Shrivastav PS., “LC-tandem mass spectrometry method for the simultaneous determination of metformin and sitagliptin in human plasma after ion-pair solid phase extraction.” J Pharm Biomed Anal. 2016; 131: 64–70.
21. Vineeta V., Rupali R., “Development and Validation of Simple UV Spectrophotometric Method for the Estimation of Dextromethorphan Hydrobromide in Bulk and Marketed Dosage Formulations” International Journal of Pharmaceutical Sciences and Drug Research 2016; 8(3): 170-173
22. V. V. Khanvilkar, R. Kothekar, “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; 170–173.
23. J. Dahiya, A. Singh, S. Kumar Gupta, B. Kumar, “Spectrophotometric Estimation of Dextromethorphan in Bulk Drug using Hydrotropic Solubilization Technique” Asian J. Pharm. Ana. 3; 90–93.
24. T. V. Raghava Raju, N. Anil Kumar, S. Raja Kumar, A. Malleswara Reddy, N. Someswara Rao, I. Mrutyunjaya Rao., “Development and Validation of a Stability-Indicating RP-HPLC Method for the Simultaneous Estimation of Guaifenesin and Dextromethorphan Impurities in Pharmaceutical Formulations” Chromatogr. Res. Int. 2013; 1–12.
25. D. Varasala, S.K. Konidala, “Stability-indicating RP-HPLC method development & validation for simultaneous determination of doxylamine succinate and dextromethorphan hydrobromide in pharmaceutical dosage forms” Der Pharm. Lett. 2015; 7;112–118.
26. P. Amaratunga, M. Clothier, B.L. Lemberg, D. Lemberg, “Determination of dextromethorphan in oral fluid by LC-MS-MS” J. Anal. Toxicol. 2016; 40; 360–366.
27. K. Souza Seba, V. Berg Cattani, J.C. Saraiva Gonçalves, R. Vianna-Jorge, R.D.C. Elias Estrela, “A novel and simple LCMS/MS quantitative method for dextromethorphan and dextrorphan in oral fluid, Bioanalysis.” 2019; 11; 913-922.
28. S.K. Gandhi, Santosh V., Dyandyan., “Development and validation of stability indicating HPTLC method for estimation of dextromethorphan hydrobromide” J. Appl. Pharm. Res. 2019; 5; 27–33.
29. K. Bhavya Sri, G. Sri vani Shailaja, Narmada Valla Keerthi., “Development and validation of UV spectrophotometric method for simultaneous estimation of Sitagliptin and Metformin in bulk and combined pharmaceutical formulation” International Journal of Current Pharmaceutical Research, 2022; 14(2); 65-68.
30. Pathade A., Imran M., Bairagi V., Ahire Y., “Development and Validation of Stability Indicating UV Spectrophotometric Method for the Estimation of Sitagliptin Phosphate in Bulk and Tablet Dosage Form.” Journal of Pharmacy Research. 2011: 4(3); 871-873.
31. R. Lavanya, Md. Yunoos, “Development and Validation of RP-HPLC method for the estimation of Sitagliptin Phosphate in Bulk and its Tablet Dosage Form” Journal of advanced pharmacy education and research, 2013; 3(4); 475-479.
32. T. Raja and A. Lakshmana Rao. “Validated HPTLC method for simultaneous estimation of metformin hydrochloride and sitagliptin phosphate in bulk drug and formulation” Rasāyan J. Chem, 2012; 5(3); 407-413.
33. Sharifa Sultana, Md. Shahadat Hossain, Md. Samiul Islam and Abu Shara Shamsur Rouf, “Quantitation of Sitagliptin in Drug Product by Validated Reversed Phase Liquid Chromatographic Technique” Dhaka Univ. J. Pharm. Sci, 2018; 17(1); 123-129.
34. Suleman S. Khoja and Laxman J. Patel, “Development and Validation of New Analytical LCMS/MS Method for the Estimation of Antidiabetic Drugs Ertugliflozin and Sitagliptin in Combined Pharmaceutical Dosage form” Journal of Pharmaceutical Research International, 2021; 33(30A); 194-204.
35. Mohamed Salim, Nahed El-Enany, Fathallah Belal, Mohamed Walash, “Simultaneous Determination of Sitagliptin and Metformin in Pharmaceutical Preparations by Capillary Zone Electrophoresis and its Application to Human Plasma Analysis,” Analytical Chemistry Insights, 2012; 7; 31–46.
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Published
Oct 03, 2025
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How to Cite
Gopal B. Sosa, Dr. Neha Tiwari, & Dr. Pragnesh Patani. (2025). A COMPREHENSIV REVIEW ON ANALYTICAL METHODS FOR ESTIMATION OF DEXTROMETHORPHAN AND SITAGLIPTIN. Journal of Population Therapeutics and Clinical Pharmacology, 32(7), 1753-1763. https://doi.org/10.53555/6ekwt957
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Author Biographies
Gopal B. Sosa
Khyati College of Pharmacy, Ahmedabad, Gujarat, India.
Dr. Neha Tiwari
Department of Pharmaceutical Chemistry, Khyati College of Pharmacy, Gujarat Technological University, Ahmedabad, Gujarat, India.
Dr. Pragnesh Patani
Department of Pharmacology, Khyati College of Pharmacy, Gujarat Technological University, Ahmedabad, Gujarat, India.
How to Cite
Gopal B. Sosa, Dr. Neha Tiwari, & Dr. Pragnesh Patani. (2025). A COMPREHENSIV REVIEW ON ANALYTICAL METHODS FOR ESTIMATION OF DEXTROMETHORPHAN AND SITAGLIPTIN. Journal of Population Therapeutics and Clinical Pharmacology, 32(7), 1753-1763. https://doi.org/10.53555/6ekwt957