Simultaneous Estimation of Saxagliptin Hydrochloride and Metformin Hydrochloride in Active Pharmaceutical Ingrident by RP-HPLC


  • Shridhar University, P.G.Department of Pharmaceutical Sciences, Pilani, Rajasthan, India
  • Alwar Pharmacy College, Analytical Chemistry Research Laboratory, Alwar, Rajasthan, India


A new simple, accurate, precise and reproducible RP - HPLC method has been developed for the simultaneous estimation of Saxagliptin and Metformin in bulk drug form using C18 column (Phenomenex, 250 x 4.6 mm, 5 μm) in isocratic mode. The mobile phase consisted of 0.02M Potassium dihydrogen phosphate (KH 2 PO 4) , Acetonitrile , Methanol in the ratio of 50 : 2 5 :25 (v/v /v) at pH 4.3 . The detection w avelength was carried out at 240 nm. The method was linear over the concentra tion range for Saxagliptin 1 0 - 5 0μg/ml and for Metformin 5 - 25μg/ml. The recoveries of Saxagliptin and Metformin were found to be 100.48and 101 . 1 % respectively. The validation of method was carried out utilizing ICH - guidelines. The described HPLC method was successfully employed for the analysis of pharmaceutical formulations containing combined dosage form.


Saxagliptine Metformine, Simultaneous Estimation , RP - HPLC.

Subject Discipline

Pharmacy and Pharmacology

Full Text:


Onglyza Product information. Bristol-Meyers-Squibb. Princeton New Jersey, USA. 1st July 2009. Available at: (cited 1st August 2010).

Australian Drug Evaluation Committee Recommendations. Australian Government Department of Health and Aging, January 2010. Available at: html/adec/adec0267.htm (cited 30th Sept 2010)

Deacon CF, Holst JJ., 2009 ,Saxagliptin: a New Dipeptidyl Peptidase-4 Inhibitor for the Treatment of Type 2 Diabetes, Adv Ther,26(5),488-499.

Robertson JG. ,2005, Discovery and Preclinical profile of Saxagliptin (BMS-477118): A highly potent, long-acting, orally active dipeptidyl peptidase IV inhibitor for the treatment of type 2 diabetes , J Med Chem,48(15), 5025- 37.

Kania, DS, Gonzalvo JD, Weber ZA, 2011 ,Saxagliptin: A Clinical Review in the Treatment of Type 2 diabetes mellitus, Clin Ther,33,1005-1022.

Deanna KS., Jasmine GD., Zachary WA., Kulasa K., Edelman S,2010,Saxagliptin: the evidence for its place in the treatment of type 2 diabetes mellitus, Core evidence,5,23-37.

Tahrani AA, Piya MK., Barnett AH, 2011, Saxagliptin: a New DPP-4 Inhibitor for the treatment of Type 2 diabetes mellitus, Adv Ther, 26(3), 249-262.

Carolyn DF. Jens HJ.,2011, Saxagliptin: a new dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. Adv Ther, 26(5), 488-499.

Singh S., Sethi S., Khanna V.,Benjamin B.,Kant R., Sattigeri J., Bansal VS, Bhatnagar PK., Davis JA.,2011, A potent, selective and slow-binding inhibitor of dipeptidyl peptidase-IV for the treatment of type 2 diabetes ,Eur J Pharmaco,652, 157-163.

Sherwyn L.,Schwartz MD.,2010, Treatment of Elderly Patients with type 2 diabetes mellitus: A Systematic Review of the Benefits and Risks of Dipeptidy l Peptidase-4 Inhibitors, Amer.J Geria Pharmacothera, 8, 405-418.

11 Hollander P., Jia L.,Allen E., Che R.,2009, Saxagliptin Added to a Thiazolidinedione Improves Glycemic Control in Patients with type 2 diabetes and Inadequate Control on Thiazolidinedione Alone, J Clin EndocrinolMetab,94(12),4810 -19.

Yang W.,Pan C.,Tou C.,Zhao J., Nilsson IG.,2011, Efficacy and safety of saxagliptin added to metformin in Asian patients with type 2 diabetes mellitus: A randomized controlled trial, Dia Res Clin Pra,5 3(1): 1-8.

Hess C., Musshoff F., Madea B., 2011, Simultaneous identification and validated quantification of 11 oral hypoglycaemic drugs in plasma by electrospray ionisation liquid chromatography–mass spectrometry, Anal Bioanal Chem, 400, 33-41.

Kalaichelvi R, Jayachandran E,2011, Validated Spectroscopic method for the estimation of Saxagliptinin pure and from tablet formulation, Int J Pharm Pharm Sci,3, 179-180.

Campbell DB, Lavielle R, Nathan C., 1991, The mode of action and clinical pharmacology of gliclazide: a review, Diab Res Clin Prac, 14, S21-S36.

Moses R., 2009, Fixed combination of repaglinide and metformin in the management of type 2 diabetes, Diabetes, Metabolic syndrome and obesity: Targets and Therapy ,Dovepress, open access to scientific and medical research,2,101-9.

Tripathi K.D. Essential of Medical Pharmacology, 2003, 5th Edn, Jaypee Brothers Medical publisher New Delhi. pp: 515-516.

Hassasaad S.M., Mahmoud WH., Elmosallamy MA, Othman AH.,1999,Determination of metformin in pharmaceutical preparations using potentiometry, spectrofluorimetry and UV–visible spectrophotometry, Anal Chimic ,1999, 378(1-3),299-311.

Patil S.S., Bonde C. G.,2009, Development and Validation of analytical method for Simultaneous Estimation of Glibenclamide and Metformin HCl in Bulk and Tablets using UV visible spectroscopy, Int J ChemTech Res,1(4): 905-909.

Lakshmi KS, Rajesh T, Sharma S, Lakshmi S, 2009,Development and Validation of Liquid Chromatographic and UV Derivative Spectrophotometric Methods for the Determination of Metformin, Pioglitazone and Glimepiride in Pharmaceutical Formulations, Der Pharma Chemica, 1 (1),238-246.

Freddy H. Havaldar, Dharmendra L.Vairal., 2010 Simultaneous estimation of metformin hydrochloride, rosiglitazone and pioglitazone hydrochloride in the tablets dosage form., Int J AppBio Pharm Tec, 1(3),1000-1005.

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, 817(2),277-286.

Jain D, Jain S, Jain D ,Maulik A.,2008, Simultaneous Estimation of Metformin Hydrochloride, Pioglitazone Hydrochloride, and Glimepiride by RP-HPLC in Tablet Formulation .J Chromatogr Sci,46,501-504.

Lakshmi KS, Rajesh T,Sharma S.,2009,Simultaneous determination of metformin and pioglitazone by reversed phase HPLC in pharmaceutical dosage forms, Int J Pharm Pharm sci, 1(2), 162-166.

Alexandar S, Diwedi R, Chandrasekar M.,2010, A RP-HPLC method for simultaneous estimation of metformin and pioglitazone in pharmaceutical formulation, Res J Pharm Bio Chem Sci, 1(4), 858-866.

Florentin T, Monica A., 2007 Specificity of an analytical HPLC assay method of metformin hydrochloride,Revue Roumaine de Chimie, 52(6), 603–609.

Ranetti M, Ionescu M, Hinescu L, Ionica E,Anuţa V, Aurelian E. et al.,2009,Validation of a HPLC method for the simultaneous analysis of metformin and gliclazide in human plasma, Farmacia, 57 (6), 729-735.

Pawar S, Meshram G, Jadhav R,Bansal Y.,2010,Simultaneous determination of Glimepiride and Metformin hydrochloride impurities in sustained release pharmaceutical drug product by HPLC , Der Pharma Chemica, 2(4), 157-168.

Havele S, Dhaneshwar S., 2010, Development and validation of a HPLC method for the determination of metformin hydrochloride, gliclazide and piogliglitazone hydrochloride in multicomponent formulation. Webmed central pharmaceutical sciences,1(10):wmc001078

Al-Rimawi F, 2009 Development and validation of an analytical method for metformin hydrochloride and its related compound (1-cyanoguanidine) in tablet formulations by HPLC-UV, Talanta, 79(5),1368-71. Epub 2009 Jun 9.

Havele S, Dhaneshwar S., 2010, Estimation of Metformin in Bulk Drug and in Formulation by HPTLC, J Nanomedic Nanotechnolo, 1: 102.doi:10.4172/2157-7439.1000102.

Georgita C, Albu F, David V, Medvedovici, 2007, A. Simultaneous assay of metformin and glibenclamide in human plasma based on extraction-less sample preparation procedure and LC /(APCI)MS. J Chromatogra B, 854(1-2), 211-218.


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