European Journal of Chemistry 2013, 4(4), 444-449 | doi: https://doi.org/10.5155/eurjchem.4.4.444-449.844 | Get rights and content






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Development and validation of a reversed phase liquid chromatographic method for the determination of three Gliptins and Metformin in the presence of Metformin impurity (1-cyanoguanidine)


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 | Revised: 26 Jul 2013 | Accepted: 18 Aug 2013 | Published: 31 Dec 2013 | Issue Date: December 2013

Abstract


A simple and precise liquid chromatographic method has been developed and validated for the determination of either sitagliptin (STG), vildagliptin (VLG) or saxagliptin HCL (SXG) and metformin HCL (MET) in the presence of metformin degradation product, 1-cyanoguanidine (CGN). Chromatographic separation was achieved on a Symmetry® cyanide column (150 mm × 4.6 mm, 5 μm). Isocratic elution using a mobile phase of potassium dihydrogen phosphate buffer (pH = 4.6) - acetonitrile (30:70, v:v) at a flow rate of 1 mL/min with UV detection at 210 nm was performed. The LC method was used for the simultaneous determination of STG, VLG, SXG and MET in the ranges of 5-200, 5-200, 0.5-80.0 and 20-800 μg/mL, respectively. The results were statistically compared with the reference method for each drug using one-way analysis of variance (ANOVA). The method developed was satisfactorily applied to the analysis of the pharmaceutical formulations and proved to be specific and accurate for the quality control of the cited drugs in pharmaceutical dosage forms.

4_4_444_449

Keywords


Sitagliptin; Metformin; Saxagliptin; Vildagliptin; Liquid chromatography; Stability indicating assay

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DOI: 10.5155/eurjchem.4.4.444-449.844

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[1]. Sonia T Hassib, Elham A Taha, Ehab F Elkady, Ghada H Barakat
Validated Liquid Chromatographic Method for the Determination of (Canagliflozin, Dapagliflozin or Empagliflozin) and Metformin in the Presence of (1-Cyanoguanidine)
Journal of Chromatographic Science  57(8), 697, 2019
DOI: 10.1093/chromsci/bmz042
/


[2]. Wafaa A. Zaghary, Shereen Mowaka, Moataz S. Hendy
Sample Enrichment of Canagliflozin Prior to Its Spectrophotometric Determination in Presence of Metformin: Application to Recently Approved Binary Dosage Form
Journal of Analytical Chemistry  75(6), 742, 2020
DOI: 10.1134/S1061934820060180
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[3]. 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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[4]. 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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[5]. Asmaa A. El-Zaher, Ehab F. Elkady, Hanan M. Elwy, Mahmoud Abo El Makarim Saleh
A new rapid and economic liquid chromatographic method for simultaneous determination of meglitinides with metformin: application in the presence of metformin and repaglinide impurities and related compounds
Journal of the Iranian Chemical Society  15(1), 61, 2018
DOI: 10.1007/s13738-017-1209-7
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[6]. Eman I. El-Kimary, Dalia A. Hamdy, Sara S. Mourad, Magda A. Barary
HPTLC Determination of Three Gliptins in Binary Mixtures with Metformin
Journal of Chromatographic Science  , bmv106, 2015
DOI: 10.1093/chromsci/bmv106
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[7]. 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), 444-449. doi:10.5155/eurjchem.4.4.444-449.844
El-Bagary, R.; Elkady, E.; Ayoub, B. Development and validation of a reversed phase liquid chromatographic method for the determination of three Gliptins and Metformin in the presence of Metformin impurity (1-cyanoguanidine). Eur. J. Chem. 2013, 4(4), 444-449. doi:10.5155/eurjchem.4.4.444-449.844
El-Bagary, R., Elkady, E., & Ayoub, B. (2013). Development and validation of a reversed phase liquid chromatographic method for the determination of three Gliptins and Metformin in the presence of Metformin impurity (1-cyanoguanidine). European Journal of Chemistry, 4(4), 444-449. doi:10.5155/eurjchem.4.4.444-449.844
El-Bagary, Ramzia, Ehab Farouk Elkady, & Bassam Mahfouz Ayoub. "Development and validation of a reversed phase liquid chromatographic method for the determination of three Gliptins and Metformin in the presence of Metformin impurity (1-cyanoguanidine)." European Journal of Chemistry [Online], 4.4 (2013): 444-449. Web. 6 Aug. 2020
El-Bagary, Ramzia, Elkady, Ehab, AND Ayoub, Bassam. "Development and validation of a reversed phase liquid chromatographic method for the determination of three Gliptins and Metformin in the presence of Metformin impurity (1-cyanoguanidine)" European Journal of Chemistry [Online], Volume 4 Number 4 (31 December 2013)

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DOI Link: https://doi.org/10.5155/eurjchem.4.4.444-449.844

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