A VALIDATED STABILITY INDICATING ULTRA-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN BULK DRUG AND TABLET DOSAGE FORM


N. Madana Gopal, C. Sridhar

Abstract


Objective: To develop a simple, precise, accurate, method was developed and validated for analysis of metformin hydrochloride (MET) and empagliflozin in (EMPA) in bulk and tablet dosage form.

Methods: The method used a reverse phase column, dikma C18 (50×2.1 mm, 1.8 μ), a mobile phase comprising of phosphate buffer (pH-3): methanol (30:70 v/v) flow rate of 1.0 ml/min and a detection wavelength of 240 nm using a photodiode array detector. The proposed method was validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits, stability studies, formulation analysis as per International Conference on Harmonization (ICH) guidelines.

Results: The retention time was found to be 1.189 min and 1.712 min for MET and EMPA respectively. The proposed method was found to be having linearity in the concentration range of 500-2500 μg/ml for MET (r2=0.989) and 5-25 μg/ml for EMPA (r2=0.994), respectively. The mean % recoveries obtained were found to be 100.35-100.48% for MET and 99.80-101.30% for EMPA respectively. Stress testing which covered acid, base, peroxide, photolytic and thermal degradation was performed on under test to prove the specificity of the method and the degradation was achieved. The developed method has been statistically validated according to International Conference on Harmonization (ICH) guidelines.

Conclusion: Thus, the proposed method can be successfully applied for the stability indicating the simultaneous determination of MET and EMPA in bulk and combined tablet dosage form and in the routine quality control analysis.


Keywords


Empagliflozin, Metformin hydrochloride, Reversed-phase ultra-performance liquid chromatography, Validation

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About this article

Title

A VALIDATED STABILITY INDICATING ULTRA-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN BULK DRUG AND TABLET DOSAGE FORM

Keywords

Empagliflozin, Metformin hydrochloride, Reversed-phase ultra-performance liquid chromatography, Validation

DOI

10.22159/ijap.2017v9i3.17441

Date

01-05-2017

Additional Links

Manuscript Submission

Journal

International Journal of Applied Pharmaceutics
Vol 9, Issue 3, 2017 Page: 45-50

Online ISSN

0975-7058

Statistics

228 Views | 33 Downloads

Authors & Affiliations

N. Madana Gopal
Research scholar, Rayalaseema university, Kurnool. Andhra Pradesh, India
India

C. Sridhar
2Department of Pharmaceutical Analysis, Sri Padmavathi School of Pharmacy, Tirupathi. Andhra Pradesh, India
India


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