Author(s):
Maruthi R, Chandan R. S, Anand Kumar Tengli
Email(s):
maruthireddy666@gmail.com
DOI:
10.5958/0974-360X.2020.00631.9 
Address:
Maruthi R*, Chandan R. S1, Anand Kumar Tengli2
Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru-570015, Karnataka.
*Corresponding Author
Published In:
Volume - 13,
Issue - 8,
Year - 2020
ABSTRACT:
An accurate and lively LC-MS/MS and NMR analytical methods have been developed for recognition and characterization of key impurities in Teneligliptin. Teneligliptin is an anti-diabetic drug used to treat Diabetes mellitus Type II and three unknown impurities were detected in Teneligliptin bulk drug substance using RP-UFLC method at RT 4.02 min, 5.09 min and 6.2 min. These impurities were isolated by preparative HPLC and further characterized by using LC-MS/MS and NMR techniques. LC-MS/MS analysis was performed using C18 reverse phase column and with Methanol and Ammonium Formate (80:20) as a mobile phase. The flow rate was maintained at 0.5mL/min with injection volume as 10 µL. The separations were achieved with binary gradient program and the column is maintained with ambient temperature. The MS conditions adopted for this analysis with scan range of m/z = 50 to 500 with dwell time 3 seconds. NMR was carried out using DMSO as solvent. Based on spectral data, the impurities have been characterized as IMP 3, IMP 5 and IMP E.
Cite this article:
Maruthi R, Chandan R. S, Anand Kumar Tengli. Characterization of impurities in Teneligliptin hydrobromide hydrate by using LCMS/MS and NMR. Research J. Pharm. and Tech. 2020; 13(8):3569-3576. doi: 10.5958/0974-360X.2020.00631.9
Cite(Electronic):
Maruthi R, Chandan R. S, Anand Kumar Tengli. Characterization of impurities in Teneligliptin hydrobromide hydrate by using LCMS/MS and NMR. Research J. Pharm. and Tech. 2020; 13(8):3569-3576. doi: 10.5958/0974-360X.2020.00631.9 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2020-13-8-4
REFERENCES:
1. Luhar SV, Pandya KR, Jani GK, Sachin B, Narkhed S: Simultaneous estimation of teneligliptin hydrobromide hydrate and its degradation product by RPHPLC method. J Pharm Sci Bioscientific Res. 2016; 6(3):254-61.
2. Kumar TG, Vidyadhara S, Narkhede NA, Silpa YS, and Lakshmi MR: Method development, validation, and stability studies of teneligliptin by RP-HPLC and identification of degradation products by UPLC tandem mass spectroscopy. Journal of Analytical Science and Technology. 2016 Dec 1; 7(1):27.
3. Patil MD, Bapna M, Shah P, and Khoja SS: Development and Validation of Analytical Method for Simultaneous Estimation of Metformin Hydrochloride and Teneligliptin Hydrobromide Hydrate in Pharmaceutical Dosage Form. J Pharm Sci Bioscientific Res. 2017; 7(2):200-108.
4. Yadav N, Goyal A: Method development and validation of Teneligliptin in pharmaceutical dosage form by UV spectrophotometric methods. International Journal of Pharmaceutical Chemistry and Analysis. 2017; 4(3):54-8.
5. Patel KB, Joshi HV, Shah UA, Patel JK: Development and Validation of Analytical Method for Simultaneous Estimation of Teneligliptin Hydrobromide Hydrate and Metformin Hydrochloride in Pharmaceutical Dosage Form. Pharma Science Monitor. 2017 Oct 1; 8(4).
6. Shaikh AR, Ahmed BA, Ibrahim M: A Validated Stability Indicating Rp–Hplc Method for Simultaneous Estimation of Metformin and Teneligliptin in Bulk and Pharmaceutical Dosage Form.
7. Sunitha PG, Karthikeyan R, Ranjith Kumar B, Muniyappan S: Quantitative Estimation of Teneligliptin By Validated Colorimetric and FTIR Spectroscopic Methods.
8. Chitlange SS, Rawat DG, Gandhi SP: Estimation of Anti Diabetic Teneligliptin in Bulk and Formulation by Densitometric and Spectrophotometric Method. Analytical Chemistry Letters. 2017 Jul 4; 7(4):556-66.
9. Patil D, Ahmad S, Shastry VM, Mujawar T, Thakare L: Analytical method development and validation for the simultaneous estimation of Metformin and Teneligliptin by RP-HPLC in bulk and tablet dosage forms. Journal of Pharmacy Research Vol. 2017 Jun; 11(6):676-81.
10. Sen AK, Hinsu DN, Sen DB, Zanwar AS, Maheshwari RA: Analytical method development and validation for simultaneous estimation of Teneligliptin hydrobromide hydrate and Metformin hydrochloride from its pharmaceutical dosage form by three different UV spectrophotometric methods.
11. Kumar TG, Vidyadhara S, Narkhede NA, Silpa YS, Lakshmi MR. Method development, validation, and stability studies of teneligliptin by RP-HPLC and identification of degradation products by UPLC tandem mass spectroscopy. Journal of Analytical Science and Technology. 2016 Dec 1;7(1):27.
12. Ali F, Nandi U, Trivedi M, Prakash A, Dahiya M, Sahu PL, Kumar R, Singh GN. Quantitative characterization and pharmaceutical compatibility between teneligliptin and widely used excipients by using thermal and liquid chromatography tandem mass spectrometry techniques. Journal of Thermal Analysis and Calorimetry. 2018 Apr 1; 132(1):385-96.