A NOVEL STABILITY-INDICATING REVERSE PHASE LIQUID CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF METFORMIN AND TENELIGLIPTIN IN PURE AND PHARMACEUTICAL FORMULATIONS
DOI:
https://doi.org/10.22159/ijap.2018v10i5.29568Keywords:
Method validation, Estimation, Stability indicating, RP-HPLC, Metformin, TeneligliptinAbstract
Objective: The present method was proposed to develop a simple, sensitive, rapid, accurate and stability-indicating reverse phase-high performance liquid chromatographic (RP-HPLC) method for the simultaneous estimation of metformin and teneligliptin in pure and pharmaceutical formulations.
Methods: The chromatographic separation was done on Discovery [250 mm X 4.6 mm: 5 μm is particle size] using a mobile phase composed of 0.1% orthophosphoric acid buffer: acetonitrile [65:35, v/v], the flow rate is 1 ml/min and the detection was carried out with a photodiode array (PDA) at 260 nm.
Results: The retention time of metformin and teneligliptin were found to be 2.517 min and 3.687 min, respectively. Stability indicating studies were conducted under the guidelines of an international conference on harmonization [ICH] Q1A R2 and the developed method was validated as per the guidelines of ICH Q2 R1. The linearity was found in the range of concentration of 125-750 μg/ml and 5-30 μg/ml for metformin and teneligliptin. The lower limit of detection (LOD) and lower limit of quantification (LOQ) was found to be 0.02μg/ml and 0.07 μg/ml for metformin and 0.19 μg/ml and 0.56 μg/ml for teneligliptin, respectively.
Conclusion: A novel stability-indicating reverse phase liquid chromatographic method developed for the simultaneous estimation of metformin and teneligliptin. The proposed method was adopted for the routine estimation of metformin and teneligliptin in bulk and pharmaceutical dosage forms.Downloads
References
Marc F, Bruno G, Luc B, Michael P, Benoit V. Metformin: from mechanics of action to therapies. Cell Metab 2014;20:953-66.
Miyako K. Teneligliptin: a DPP-4 inhibitor for the treatment of type 2 diabetes. Diabetics Metabolic Syndrome Obesity: Targets Therapy 2013;6:187-95.
Kaushelendra M, Himesh S, Nayak G, Patel SS, Singhai AK. Method development and validation of metformin hydrochloride in tablet dosage form. E J Chem 2011;8:1309-13.
Chirag, Amrita P. Development, and validation of UV spectrophotometric method for simultaneous estimation of metformin hydrochloride and alogliptin benzoate in bulk drugs and combined dosage forms. Pharm Chem 2014;6:303-11.
Ravi K, Ramesh B, Garima K, Rubina B. Development and validation of novel spectrophotometric method for simultaneous estimation of pioglitazone and metformin in bulk and fixed dosage form by Area under curve and Dual wavelength mode. Int J Appl Pharm 2016;8:48-53.
Ashim KS, Denish NH, Dhanya BS, Aarti SZ, Rajesh AM, Vikas RC. 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. J Appl Pharm Sci 2016;6:157-65.
Murthy TGK, Geethanjali J. Development of a validated RP-HPLC method for simultaneous estimation of metformin hydrochloride and rosuvastatin calcium in bulk and in-house formulation. J Chromatogr Sep Tech 2014;5:252-9.
Doredla NR, Mannepalli C. Method development and validation of rp-hplc method for simultaneous analysis of three component tablet formulation containing metformin hydrochloride, pioglitazone hydrochloride and glibenclamide. Int J Pharm Tech Res 2012;4:948-56.
Geetha SP, Lakshmana RK, Prasad KRS, Suresh BK. Development and validation of stability are indicating a reverse phase high-pressure liquid chromatography method for simultaneous estimation of metformin and empagliflozin in bulk and tablet dosage form. Asian J Pharm Clin Res 2016;9:126-35.
Deepak P, Sufiyan A, Shastry VM, Tabrej M, Lalit T. Analytical method development and validation for simultaneous estimation of metformin and teneligliptin by RP-HPLC in bulk and dosage form. J Pharm Res 2017;11:676-81.
Madana GN, Sridhar C. A validated stability indicating Ultra performance liquid chromatographic method for simultaneous estimation of metformin hydrochloride and empagliflozin in bulk and tablet dosage form. Int J Appl Pharm 2017;9:45-50.
Kumar TNVG, Vidyadhara S, Ashok NN, Sai SY, Lakshmi, Rajyalakshmi M. Method development, validation, and stability studies of teneligliptin by rp-hplc and identification of degradation products by UPLC tandem mass spectroscopy. J Anal Sci Tech 2016;7:18-26.
James DTB, Kannappan, Sasijith, Suresh K. Simultaneous estimation and method development for L-Carnitine and metformin in human plasma using the liquid chromatography-mass spectrometer. Asian J Pharm Clin Res 2015;8:185-91.
Raja HBC, Gowri SD. Development and validation of lc-ms/ms method for quantification of teneligliptin in human plasma and its application to a pharmacokinetic study. World J Pharm Pharm Sci 2016;5:838-50.
Guidelines for validation of Analytical Procedures, Q2(R1), ICH; 2005.
Guideline on stability testing of new drug substances and products text and methodology, Q1A (R2), ICH; 2003.
Patil M, Jani HD, Khoja SS, Pirani NA, Shamim SK. A review on chemistry and pharmacological activity of metformin hydrochloride and teneligliptin hydrobromide in the combined dosage form. Pharma Tutor 2017;5:24-30.
Published
How to Cite
Issue
Section
