Development of validated RP-HPLC method for antidiabetic drugs in pharmaceutical dosage form

Authors

  • Manoj S. Charde Department of Quality Assurance, Government College of Pharmacy, Kathora Naka, Amravati-444604

Keywords:

MET, PIOG, RP-HPLC, Method Validation, Assay method

Abstract

A RP-HPLC method was developed using Comosil RP-C18 (4.6 x 150mm, 5µm) as stationary phase with younglin (S.K.) isocratic system UV detector in a gradient mode with mobile phase comprising of Acetonitrie : Pott. Dihydrogen Phosphate (adjusted pH-2.5 using OPA). 0.7ml/min flow rate and monitoring of effluent were done at 254.0 nm for MET (Metformin) and PIOG(Pioglitazone) estimation in combined dosage form. 2.1 min for MET and 7.53 min for PIOG retention times were found. The dynamic range of linearity 50.0- 250.0 µg/mL for METand 3.0- 15.0 µg/mL for PIOG were exhibited for the assay. The linear calibration curves were found over the entire range linearity (r2 = 0.996for MET and r2 = 0.995for PIOG) and99.81%for MET and 99.33% for PIOG mean % recovery was found with % RSD was NMT 2.0 for both estimations which fully agrees by system suitability in good agreement with labeled claimed of formulation. The % RSD for Intra & Inter-Day Precision was NMT than 2.0 for both drugs. The developed method was accurate, precise, rugged and linear as per ICH guidelines

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Published

2015-12-30

Issue

Vol. 5 No. 12 (2015): Dec

Section

Research Articles

License

Copyright (c) 2015 International Journal of Pharmaceutical Chemistry

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How to Cite

1.
Development of validated RP-HPLC method for antidiabetic drugs in pharmaceutical dosage form. Int J of Pharm Chem [Internet]. 2015 Dec. 30 [cited 2026 Jan. 4];5(12):417-29. Available from: https://ssjournals.co.in/index.php/ijpc/article/view/5365