European Journal of Chemistry 2013, 4(4), 360-365. doi:10.5155/eurjchem.4.4.360-365.843

Simultaneous determination of sitagliptin and metformin in ternary mixture with sitagliptin acid degradation product


Ramzia Ismail El-Bagary (1) , Ehab Farouk Elkady (2) , Bassam Mahfouz Ayoub (3,*)

(1) Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt
(2) Pharmaceutical Chemistry Department, Faculty of Pharmacy, Cairo University, Cairo 11562, Egypt
(3) Pharmaceutical Chemistry Department, Faculty of Pharmacy, British University in Egypt, El-Sherouk, Cairo 11837, Egypt
(*) Corresponding Author

Received: 04 Jun 2013, Accepted: 05 Jul 2013, Published: 31 Dec 2013

Abstract


In this work, the acidic degradation product of sitagliptin phosphate monohydrate (STG) was synthesized, separated and its structure was elucidated. Additionally, two reversed-phase liquid chromatographic (RP-LC) methods have been developed for the determination of STG. The first method comprised the determination of STG in binary mixture with sitagliptin acid degradation product (SDP) in laboratory prepared mixtures, in plasma and in dosage form. This method was based on isocratic elution using a mobile phase consisting of potassium dihydrogen phosphate buffer (pH =4.6) - acetonitrile (30:70, v:v) with fluorometric detection. The fluorometric detector was operated at 267 nm for excitation and 575 nm for emission. In the second method, the simultaneous determination of STG and metformin (MET) in the presence of SDP has been developed. In this method, the ternary mixture of STG, MET and SDP was separated using a mobile phase consisting of potassium dihydrogen phosphate buffer (pH = 4.6) - acetonitrile (15:85, v:v) with UV detection at 220 nm. Chromatographic separation in the two methods was achieved on a Symmetry® Waters C18 column (150 mm × 4.6 mm, 5 μm). The optimized methods were validated and proved to be specific, robust and accurate for the quality control of the cited drugs in pharmaceutical preparations.

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Keywords


Metformin; Sitagliptin phosphate; Stability indicating assay; Pharmaceutical preparation; Sitagliptin degradation product; Reversed-phase liquid chromatography

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DOI: 10.5155/eurjchem.4.4.360-365.843

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Citations

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[1]. Wafaa A. Zaghary, Shereen Mowaka, Moataz S. Hendy
Comparative Liquid Chromatographic Study for Concurrent Determination of Canagliflozin and Metformin in Combined Tablets
Journal of Analytical Methods in Chemistry  2017, 1, 2017
DOI: 10.1155/2017/9197230
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[2]. Bassam M. Ayoub
UPLC simultaneous determination of empagliflozin, linagliptin and metformin
RSC Advances  5(116), 95703, 2015
DOI: 10.1039/C5RA17231D
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[3]. Shereen Mowaka, Dalia Mohamed
Novel contribution to the simultaneous analysis of certain hypoglycemic drugs in the presence of their impurities and degradation products utilizing UPLC-MS/MS
RSC Advances  5(74), 60467, 2015
DOI: 10.1039/C5RA11448A
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[4]. Wafaa A. Zaghary, Shereen Mowaka, Moataz S. Hendy
Kinetic Degradation Study of Dapagliflozin Coupled with UHPLC Separation in the Presence of Major Degradation Product and Metformin
Chromatographia  82(4), 777, 2019
DOI: 10.1007/s10337-019-03702-3
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How to cite


El-Bagary, R.; Elkady, E.; Ayoub, B. Eur. J. Chem. 2013, 4(4), 360-365. doi:10.5155/eurjchem.4.4.360-365.843
El-Bagary, R.; Elkady, E.; Ayoub, B. Simultaneous determination of sitagliptin and metformin in ternary mixture with sitagliptin acid degradation product. Eur. J. Chem. 2013, 4(4), 360-365. doi:10.5155/eurjchem.4.4.360-365.843
El-Bagary, R., Elkady, E., & Ayoub, B. (2013). Simultaneous determination of sitagliptin and metformin in ternary mixture with sitagliptin acid degradation product. European Journal of Chemistry, 4(4), 360-365. doi:10.5155/eurjchem.4.4.360-365.843
El-Bagary, Ramzia, Ehab Farouk Elkady, & Bassam Mahfouz Ayoub. "Simultaneous determination of sitagliptin and metformin in ternary mixture with sitagliptin acid degradation product." European Journal of Chemistry [Online], 4.4 (2013): 360-365. Web. 22 Sep. 2019
El-Bagary, Ramzia, Elkady, Ehab, AND Ayoub, Bassam. "Simultaneous determination of sitagliptin and metformin in ternary mixture with sitagliptin acid degradation product" European Journal of Chemistry [Online], Volume 4 Number 4 (31 December 2013)

DOI Link: https://doi.org/10.5155/eurjchem.4.4.360-365.843

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