How to cite this paper
Patel, V., Pandya, C., Patel, Z., Patel, D & Pandya, A. (2021). Isocratic RP-UHPLC method development and validation of stability-indicating for simultaneous determination of teneligliptin and metformin in fixed-dose combination.Current Chemistry Letters, 10(4), 503-516.
Refrences
1. Cho NH, Shaw JE, Karuranga S, Huang Y, Rocha JD, Ohlrogge AW, Malanda B. (2018) IDF Diabetes Atlas : Global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res. Clin. Pract., 138, 271–281.
2. Mistri HN, Jangid AG, Shrivastav PS. (2007) Liquid chromatography tandem mass spectrometry method for simultaneous determination of antidiabetic drugs metformin and glyburide in human plasma. J Pharm Biomed Anal. 45(1), 97–106.
3. Salim M, El-enany N, Belal F, Walash M, Patonay G. (2012) Simultaneous Determination of Sitagliptin and Metformin in Pharmaceutical Preparations by Capillary Zone Electrophoresis and its Application to Human Plasma Analysis. Anal. Chem. Insights. 7, 31-46.
4. Shah, P. A., Shah, J. V., Sanyal, M., & Shrivastav, P. S. (2017) LC-MS/MS analysis of metformin, saxagliptin and 5-hydroxy saxagliptin in human plasma and its pharmacokinetic study with a fixed-dose formulation in healthy Indian subjects. Biomed. Chromatogr., 31(3).
5. Yoshida T, Akahoshi F, Sakashita H, Kitajima H, Nakamura M, Sonda S, Takeuchi M, Tanaka Y, Ueda N, Sekiguchi S, Ishige T, Shima K, Nabeno M, Abe Y, Anabuki J, et al. (2012) Discovery and preclinical profile of teneligliptin (3-[(2S,4S)-4-[4-(3- methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl]pyrrolidin-2-ylcarbonyl] thiazolidine): A highly potent, selective, long-lasting and orally active dipeptidyl peptidase IV inhibitor for. Bioorganic Med. Chem., 20 (19), 5705–5719.
6. Chitlange SS, Rawat DG, Gandhi SP. (2017) Estimation of Anti Diabetic Teneligliptin in Bulk and Formulation by Densitometric and Spectrophotometric Method. Anal. Chem. Lett., 7 (4), 556–566.
7. Kumar TNVG, Vidyadhara S, Narkhede NA, Silpa YS, Lakshmi MR. (2016) Method development, validation, and stability studies of teneligliptin by RP-HPLC and identification of degradation products by UPLC tandem mass spectroscopy. J. Anal. Sci. Technol., 7 (1), 1–12.
8. Shantikumar S, Satheeshkumar N, Srinivas R. (2015) Pharmacokinetic and protein binding profile of peptidomimetic DPP-4 inhibitor - Teneligliptin in rats using liquid chromatography-tandem mass spectrometry. J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 1002, 194–200.
9. Halabi A, Maatouk H, Siegler KE, Faisst N, Lufft V, Klause N. (2013) Pharmacokinetics of teneligliptin in subjects with renal impairment. Clin. Pharmacol. Drug Dev., 2 (3), 246–254.
10. Lisa C. Holloman, Pharm.D., Stephen R. Marder, M.D. (1997) Management of acute extrapyramidal effects induced by antipsychotic drugs. Am. J. Health-Syst. Pharm., 54 (21), 2461–2477.
11. Ashour S, Kabbani R. (2003) Direct spectrophotometric determination of metformin hydrochloride in pure form and in drug formulations. Anal. Lett., 36 (2), 361–370.
12. Hassan SSM, Mahmoud WH, Elmosallamy MAF, Othman AHM. (1999) Determination of metformin in pharmaceutical preparations using potentiometry, spectrofluorimetry and UV-visible spectrophotometry. Anal. Chim. Acta., 378 (1–3), 299–311.
13. AbuRuz S, Millership J, McElnay J. (2005) The development and validation of liquid chromatography method for the simultaneous determination of metformin and glipizide, gliclazide, glibenclamide or glimperide in plasma. J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 817 (2), 277–286.
14. Cheng C, Chou C. (2001) Determination of metformin in human plasma by high-performance liquid chromatography with spectrophotometric detection. J. Chromatogr. B Biomed. Sci. Appl. 762 (1), 51–58.
15. WANG Y. (2004) Rapid and sensitive liquid chromatography?tandem mass spectrometric method for the quantitation of metformin in human plasma. J. Chromatogr. B, 808 (2), 215–219.
16. Pontarolo R, Gimenez AC, de Francisco TM, et al. (2014) Simultaneous determination of metformin and vildagliptin in human plasma by a HILIC-MS/MS method. Journal of chromatography. J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 965, 133–141.
17. Zarghi A, Foroutan SM, Shafaati A, Khoddam A. (2003) Rapid determination of metformin in human plasma using ion-pair HPLC. J. Pharm. Biomed. Anal., 31 (1), 197–200.
18. Shah PA, Shrivastav PS.(2018) Ion-pair solid phase extraction for the simultaneous separation and quantitation of metformin and canagliflozin in human plasma by LC-MS/MS. Microchem. J., 143, 181–189.
19. Chhetri HP, Thapa P, Van Schepdael A. (2014) Simple HPLC-UV method for the quantification of metformin in human plasma with one step protein precipitation. Saudi Pharm. J., 22 (5), 483–487.
20. Bryson A, Jennings PE, Deak L, Paveliu FS, Lawson M. (2016) The efficacy and safety of teneligliptin added to ongoing metformin monotherapy in patients with type 2 diabetes: a randomized study with open label extension. Expert Opin. Pharmacother., 17 (10), 1309–1316.
21. Patel VA, Pandya C, Pandya A, Kumbhani J, Patel D, Patel Z. (2019) Concurrent Determination of Teneligliptin Hydrobromide Hydrate and Metformin Hydrochloride Development and Validation by UV-VIS Spectrophotometry in Bulk and Pharmac. IJTIMES, 5 (03), 296–303.
22. Sen AK, Hinsu DN, Sen DB, Zanwar AS, Maheshwari RA, Chandrakar VR. (2016) Analytical method development and validation for simultaneous estimation of Teneligliptin hydrobromide hydrate and Metformin hydrochloride from it’s pharmaceutical dosage form by three different UV spectrophotometric methods. J. Appl. Pharm. Sci., 6 (9), 157–165.
23. Anwar Rafique Shaikh, Bakhshi Abdul Rahman Khalil Ahmed, Mohammad Ibrahim. (2018) A validated stability indicating RP - HPLC method for simultaneous estimation of Metformin and Teneligliptin in bulk and pharmaceutical dosage form. IJPSR. 9 (4), 1705–1712.
24. Zhang P, Dong S, Gu G, Huang T. (2010) Simultaneous Determination of Cd2+. Bull. Korean Chem. Soc., 31 (10), 2949–2954.
25. Sunkara Mrunal Chaitanya, Mukthinuthalapati Mathrusri Annapurna. (2018) Simultaneous Determination of Metformin and Teneligliptin by Liquid Chromatography in tablets. Asian J. Pharm., 12 (2), 736-739
26. Shah PA, Shrivastav PS, Vanol PG, Sanyal M. (2018) Mechanistic study for the simultaneous determination of metformin and teneligliptin in human plasma using hydrophilic interaction liquid chromatography-MS/MS. Bioanalysis, 10 (7), 475–488.
27. Paul D, Allakonda L, Satheeshkumar N. (2017) A validated UHPLC-QTOF-MS method for quantification of metformin and teneligliptin in rat plasma: Application to pharmacokinetic interaction study. J. Pharm. Biomed. Anal., 143, 1–8.
28. Hu X xia, Lan T, Chen Z, Yang C cheng, Tang P fei, Yuan L jing, Hu GX, Cai JP. (2016) A rapid and sensitive UHPLC–MS/MS assay for the determination of trelagliptin in rat plasma and its application to a pharmacokinetic study. J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 1033–1034, 166–171.
29. Decosterd LA, Rochat B, Pesse B, Mercier T, Tissot F, Widmer N, Bille J, Calandra T, Zanolari B, Marchetti O. (2010) Multiplex ultra-performance liquid chromatography-tandem mass spectrometry method for simultaneous quantification in human plasma of fluconazole, itraconazole, hydroxyitraconazole, posaconazole, voriconazole, voriconazole-N-oxide, anidulafungin, and caspo. Antimicrob. Agents Chemother., 54 (12), 5303–5315.
30. Kumar A, Saini G, Nair A, Sharma R. (2012) UPLC: A preeminent technique in pharmaceutical analysis. Acta Pol. Pharm. - Drug Res., 69 (3), 371–380.
31. ICH Guidance on Analytical Method Validation. (2002) International Convention on Quality for the Pharmaceutical Industry. Toronto, Canada.
32. ICH. Technical Requirements for the Registration of Pharmaceutical for Human Use. (2005) Validation of Analytical Procedures: Text and Methodology Q2(R1); IFPMA. Geneva, Switzerland, 1–13.
33. Zakeri-Milani P, Islambulchilar Z, Majidpour F, Jannatabadi E, Lotfpour F, Valizadeh H. (2014) A study on enhanced intestinal permeability of clarithromycin nanoparticles. Brazilian J. Pharm. Sci., 50 (1), 121–129.
2. Mistri HN, Jangid AG, Shrivastav PS. (2007) Liquid chromatography tandem mass spectrometry method for simultaneous determination of antidiabetic drugs metformin and glyburide in human plasma. J Pharm Biomed Anal. 45(1), 97–106.
3. Salim M, El-enany N, Belal F, Walash M, Patonay G. (2012) Simultaneous Determination of Sitagliptin and Metformin in Pharmaceutical Preparations by Capillary Zone Electrophoresis and its Application to Human Plasma Analysis. Anal. Chem. Insights. 7, 31-46.
4. Shah, P. A., Shah, J. V., Sanyal, M., & Shrivastav, P. S. (2017) LC-MS/MS analysis of metformin, saxagliptin and 5-hydroxy saxagliptin in human plasma and its pharmacokinetic study with a fixed-dose formulation in healthy Indian subjects. Biomed. Chromatogr., 31(3).
5. Yoshida T, Akahoshi F, Sakashita H, Kitajima H, Nakamura M, Sonda S, Takeuchi M, Tanaka Y, Ueda N, Sekiguchi S, Ishige T, Shima K, Nabeno M, Abe Y, Anabuki J, et al. (2012) Discovery and preclinical profile of teneligliptin (3-[(2S,4S)-4-[4-(3- methyl-1-phenyl-1H-pyrazol-5-yl)piperazin-1-yl]pyrrolidin-2-ylcarbonyl] thiazolidine): A highly potent, selective, long-lasting and orally active dipeptidyl peptidase IV inhibitor for. Bioorganic Med. Chem., 20 (19), 5705–5719.
6. Chitlange SS, Rawat DG, Gandhi SP. (2017) Estimation of Anti Diabetic Teneligliptin in Bulk and Formulation by Densitometric and Spectrophotometric Method. Anal. Chem. Lett., 7 (4), 556–566.
7. Kumar TNVG, Vidyadhara S, Narkhede NA, Silpa YS, Lakshmi MR. (2016) Method development, validation, and stability studies of teneligliptin by RP-HPLC and identification of degradation products by UPLC tandem mass spectroscopy. J. Anal. Sci. Technol., 7 (1), 1–12.
8. Shantikumar S, Satheeshkumar N, Srinivas R. (2015) Pharmacokinetic and protein binding profile of peptidomimetic DPP-4 inhibitor - Teneligliptin in rats using liquid chromatography-tandem mass spectrometry. J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 1002, 194–200.
9. Halabi A, Maatouk H, Siegler KE, Faisst N, Lufft V, Klause N. (2013) Pharmacokinetics of teneligliptin in subjects with renal impairment. Clin. Pharmacol. Drug Dev., 2 (3), 246–254.
10. Lisa C. Holloman, Pharm.D., Stephen R. Marder, M.D. (1997) Management of acute extrapyramidal effects induced by antipsychotic drugs. Am. J. Health-Syst. Pharm., 54 (21), 2461–2477.
11. Ashour S, Kabbani R. (2003) Direct spectrophotometric determination of metformin hydrochloride in pure form and in drug formulations. Anal. Lett., 36 (2), 361–370.
12. Hassan SSM, Mahmoud WH, Elmosallamy MAF, Othman AHM. (1999) Determination of metformin in pharmaceutical preparations using potentiometry, spectrofluorimetry and UV-visible spectrophotometry. Anal. Chim. Acta., 378 (1–3), 299–311.
13. AbuRuz S, Millership J, McElnay J. (2005) The development and validation of liquid chromatography method for the simultaneous determination of metformin and glipizide, gliclazide, glibenclamide or glimperide in plasma. J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 817 (2), 277–286.
14. Cheng C, Chou C. (2001) Determination of metformin in human plasma by high-performance liquid chromatography with spectrophotometric detection. J. Chromatogr. B Biomed. Sci. Appl. 762 (1), 51–58.
15. WANG Y. (2004) Rapid and sensitive liquid chromatography?tandem mass spectrometric method for the quantitation of metformin in human plasma. J. Chromatogr. B, 808 (2), 215–219.
16. Pontarolo R, Gimenez AC, de Francisco TM, et al. (2014) Simultaneous determination of metformin and vildagliptin in human plasma by a HILIC-MS/MS method. Journal of chromatography. J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 965, 133–141.
17. Zarghi A, Foroutan SM, Shafaati A, Khoddam A. (2003) Rapid determination of metformin in human plasma using ion-pair HPLC. J. Pharm. Biomed. Anal., 31 (1), 197–200.
18. Shah PA, Shrivastav PS.(2018) Ion-pair solid phase extraction for the simultaneous separation and quantitation of metformin and canagliflozin in human plasma by LC-MS/MS. Microchem. J., 143, 181–189.
19. Chhetri HP, Thapa P, Van Schepdael A. (2014) Simple HPLC-UV method for the quantification of metformin in human plasma with one step protein precipitation. Saudi Pharm. J., 22 (5), 483–487.
20. Bryson A, Jennings PE, Deak L, Paveliu FS, Lawson M. (2016) The efficacy and safety of teneligliptin added to ongoing metformin monotherapy in patients with type 2 diabetes: a randomized study with open label extension. Expert Opin. Pharmacother., 17 (10), 1309–1316.
21. Patel VA, Pandya C, Pandya A, Kumbhani J, Patel D, Patel Z. (2019) Concurrent Determination of Teneligliptin Hydrobromide Hydrate and Metformin Hydrochloride Development and Validation by UV-VIS Spectrophotometry in Bulk and Pharmac. IJTIMES, 5 (03), 296–303.
22. Sen AK, Hinsu DN, Sen DB, Zanwar AS, Maheshwari RA, Chandrakar VR. (2016) Analytical method development and validation for simultaneous estimation of Teneligliptin hydrobromide hydrate and Metformin hydrochloride from it’s pharmaceutical dosage form by three different UV spectrophotometric methods. J. Appl. Pharm. Sci., 6 (9), 157–165.
23. Anwar Rafique Shaikh, Bakhshi Abdul Rahman Khalil Ahmed, Mohammad Ibrahim. (2018) A validated stability indicating RP - HPLC method for simultaneous estimation of Metformin and Teneligliptin in bulk and pharmaceutical dosage form. IJPSR. 9 (4), 1705–1712.
24. Zhang P, Dong S, Gu G, Huang T. (2010) Simultaneous Determination of Cd2+. Bull. Korean Chem. Soc., 31 (10), 2949–2954.
25. Sunkara Mrunal Chaitanya, Mukthinuthalapati Mathrusri Annapurna. (2018) Simultaneous Determination of Metformin and Teneligliptin by Liquid Chromatography in tablets. Asian J. Pharm., 12 (2), 736-739
26. Shah PA, Shrivastav PS, Vanol PG, Sanyal M. (2018) Mechanistic study for the simultaneous determination of metformin and teneligliptin in human plasma using hydrophilic interaction liquid chromatography-MS/MS. Bioanalysis, 10 (7), 475–488.
27. Paul D, Allakonda L, Satheeshkumar N. (2017) A validated UHPLC-QTOF-MS method for quantification of metformin and teneligliptin in rat plasma: Application to pharmacokinetic interaction study. J. Pharm. Biomed. Anal., 143, 1–8.
28. Hu X xia, Lan T, Chen Z, Yang C cheng, Tang P fei, Yuan L jing, Hu GX, Cai JP. (2016) A rapid and sensitive UHPLC–MS/MS assay for the determination of trelagliptin in rat plasma and its application to a pharmacokinetic study. J. Chromatogr. B Anal. Technol. Biomed. Life Sci., 1033–1034, 166–171.
29. Decosterd LA, Rochat B, Pesse B, Mercier T, Tissot F, Widmer N, Bille J, Calandra T, Zanolari B, Marchetti O. (2010) Multiplex ultra-performance liquid chromatography-tandem mass spectrometry method for simultaneous quantification in human plasma of fluconazole, itraconazole, hydroxyitraconazole, posaconazole, voriconazole, voriconazole-N-oxide, anidulafungin, and caspo. Antimicrob. Agents Chemother., 54 (12), 5303–5315.
30. Kumar A, Saini G, Nair A, Sharma R. (2012) UPLC: A preeminent technique in pharmaceutical analysis. Acta Pol. Pharm. - Drug Res., 69 (3), 371–380.
31. ICH Guidance on Analytical Method Validation. (2002) International Convention on Quality for the Pharmaceutical Industry. Toronto, Canada.
32. ICH. Technical Requirements for the Registration of Pharmaceutical for Human Use. (2005) Validation of Analytical Procedures: Text and Methodology Q2(R1); IFPMA. Geneva, Switzerland, 1–13.
33. Zakeri-Milani P, Islambulchilar Z, Majidpour F, Jannatabadi E, Lotfpour F, Valizadeh H. (2014) A study on enhanced intestinal permeability of clarithromycin nanoparticles. Brazilian J. Pharm. Sci., 50 (1), 121–129.