An efficient RP-HPLC-based approach for simultaneous determination of sitagliptin and metformin HCl in pharmaceutical drug formulation
Ali M. Shah M.R. Zairov R. Zafar S. Ali S.I. Ansar F. Uddin K.M. Akylbekov N.
May 2024Pakistan Journal of Pharmaceutical Sciences
Pakistan Journal of Pharmaceutical Sciences
2024#37Issue 3491 - 497 pp.
This study introduces an innovative, and rapid HPLC method using reverse phase elution for the simultaneous analysis of Sitagliptin and Metformin HCl in pharmaceutical formulations. This combination was explored in bulk and solid dosage forms using Luna Phenomenex C8 column (4.6 x 250 mm, 5 µm) at ambient temperature in isocratic elution. It was found that the mobile phase comprising of 0.1% ortho-phosphoric acid, potassium dihydrogen phosphate buffer (pH 3.0) and acetonitrile in ratios 35:35:30, showed a symmetrical peak for Sitagliptin and Metformin HCl. The detection was carried out at 210nm, using a flow rate of 1.0mL/min. The method was linear over the concentration range for Sitagliptin 2.5-7.5 ppm and Metformin HCl 25-75 ppm. The assay recoveries of Sitagliptin and Metformin were found to be 100.36% and 100.20%, respectively. The LOD and LOQ for the Sitagliptin were found to be 0.201 ppm and 0.301 ppm and for Metformin HCl 0.101 ppm and 0.303 ppm, respectively. The proposed methods can be implemented for controlling quality in bulk and solid dosage forms. The analytical methods were validated as per the guideline of ICH Q2 (R2). The developed HPLC methods were effectively employed for the determination of combined dosage forms in pharmaceutical formulations.
ICH Q2 (R2) , metformin HCl , RP-HPLC , Sitagliptin , validation
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Department of Chemistry, Faculty of Science, University of Karachi, Karachi, Pakistan
H.E.J. Research Institute of Chemistry, International Center for Chemical and Biological Sciences, University of Karachi, Karachi, Pakistan
Alexander Butlerov Institute of Chemistry, Kazan Federal University, 18 Kremlevskaya Street, Kazan, Russian Federation
Department of Pharmacy, Faculty of Health Sciences, Iqra University- North campus, Karachi, Pakistan
Department of Applied Chemistry and Chemical Technology, Faculty of Science, University of Karachi, Karachi, Pakistan
Department of Pharmaceutical Chemistry, Faculty of Pharmacy, University of Karachi, Karachi, Pakistan
Korkyt Ata Kyzylorda University, Aiteke Bi Street, 29A, Kyzylorda, 120014, Kazakhstan
Department of Chemistry
H.E.J. Research Institute of Chemistry
Alexander Butlerov Institute of Chemistry
Department of Pharmacy
Department of Applied Chemistry and Chemical Technology
Department of Pharmaceutical Chemistry
Korkyt Ata Kyzylorda University
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