Method Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Metformin and Miglitol in Pharmaceutical Dosage Form

Authors

  • Faisal A. Shaikh   Gawande College of Pharmacy,Sakharkherda, Maharashtra, India
  • Ashish A Gawai  Anuradha College of Pharmacy,Chikhali, Maharashtra, India

Keywords:

Abstract

The data obtained from result and discussion it showed that the RP-HPLC method for estimation of pharmaceutical dosage form was developed successfully. The RP-HPLC analysis was performed on the PRIMESIL C18,(250*4.6)mm, 5µm particle size in the isocratic mode, at Ambient column oven temperature using Acetonitrile: Water (80:20 v/v) as mobile phase; flow rate was adjusted to 0.7 ml/min. The detection was carried out at 236nm. The average retention time for candidate drugs was found to be 3.7333 and 8.5833 min. Linearity was observed in the concentration range of 20-100 µg/ml (r2= 0.9987 and r2=0.9984). The method has been successively applied for the determination of candidate drug in tablet formulation. There was no interference from the excipients present in the tablet. The drug content was found to be 101.63% for candidate drug. Accuracy of the method was studied by the recovery studies at three different levels 80%, 100%, 120%. The % recovery was found to be within the limit of the acceptance criteria with average recovery of 98-102. According to USP, system suitability tests are integral part of chromatographic methods. They are used to reproducibility of the chromatographic system.

References

  1. Chatwal G.R., Sharma A., Instrumental Methods of Chemical Analysis, Himalaya Publishing     House, Delh 5th Edn., 2004, 1.1-1
  2. Skoog, D.A., Holler, F.J. and Nieman, T.A., In Principles of Instrumental Analysis, 5, Thomson Brooks/Cole, 1998, 329-335.
  3. Kasture A.V., Mahadik K.R., More H.N., Instrumental Methods 14(2), Niraliprakashan, Pune, 2006,44-55.
  4. Sethi, P.D., In; HPLC ‘High Performance Liquid Chromatography’, Quantitative Analysis of Pharmaceutical Formulations, 1, CBS Publishers and Distributors, New Delhi, 2001, 3-72, 116-120.
  5. Beckett A.H. and Stenlake, J.B., In; Practical Pharmaceutical Chemistry, 4(2), CBS Publishers and Distributors, New Delhi, 2002, 275-278, 281-300.
  6. Christian, G.D., In; Analytical Chemistry, 6. Jhon Wiley and Sons, 2004, 1-7.
  7. Connors, K.A., In; A Textbook of Pharmaceutical Analysis, 3, Jhon Wiley and Sons, 1999, 196-198.
  8. Brown, R.P., Reversed-Phase High Performance Liquid Chromatography, Theory, Practice and Biomedical Applications, 1982, 10-20.
  9. Saint Louis, MO, ETATS-UNIS, International Symposium on High Performance Liquid Phase Separations and Related Techniques No 22, 1998, 828(1-2), 283-286.
  10. Mohammad Yunoos, Gowri sankar D. A Validated Stability Indicating High-Performance Liquid Chromatographic Method for Simultaneous Determination of Metformin HCL and Dapagliflozin in Bulk Drug and Tablet Dosage Form. Asian J Pharm Clin Res 2015; Vol 8: Issue 3, 320-326.
  11. Pravin Kumar S, Aruna G. Analytical Method Development and Validation of Alogliptin and Metformin Hydrochloride Tablet Dosage form by RP-HPLC Method. Int Bulletin Drug Res 2013; 3(5): 58-68.
  12. Anandkimar Tengli R, Vishwanathan B. Method Development and Validation of Metformine, Pioglitazone and Glibenclamide in Tablet Dosage Form by using RP-HPLC. Biochem Anal Biochem 2013; 2(2): 130.
  13. Chittora NC,Jain A. New RP-HPLC Method of Miglitol in Tablet Dosage form Including Forced Degradation Studies and Estimation in Spiked Rabbit Plasma. J Young Pharm 2009;1(4): 364-370.
  14. Sambasiva Rao M, Ashok Kumar A. New RP HPLC method for the estimation of imatinib in pharmaceutical dosage form. ICJPIR 2016; 3(1): 72-94.
  15. Sejal Patel R, Prachi Kabra V. A Development and Validation of Analytical Method for Quantitative Estimation of Miglitol and Metformin in Combined Dosage Form. J Applied Pharm Sci 2012; 02(06): 227-229.
  16. Tatarkiewicz K, Polizzi C, Villescaz C, D’Souza LJ, Wang Y, Janssen S, et al. Combined antidiabetic benefits of exenatide and dapagliflozin in diabetic mice. Diabetes Obes Metab 2014;16(4):376-80.
  17. Lambers Heerspink HJ, de Zeeuw D, Wie L, Leslie B, List J. Dapagliflozin a glucose-regulating drug with diuretic properties in subjects with type 2 diabetes. Diabetes Obes Metab 2013;15(9):853-62.
  18. Aubry AF, Gu H, Magnier R, Morgan L, Xu X, Tirmenstein M, et al. Validated LC-MS/MS methods for the determination of dapagliflozin, a sodium-glucose co-transporter 2 inhibitor in normal and ZDF rat plasma. Bioanalysis 2010;2(12):2001-9.
  19. Sanagapati M, Lakshmi DK, Reddy NG, Sreenivasa S. Development and validation of stability - Indicating RP-HPLC method for determination of dapagliflozin. J Adv Pharm Edu Res 2014;4(3):350-3.
  20. Madhukar A, Prince A, Vijay Kumar R, Sanjeeva Y, Jagadeeshwar K, Raghupratap D. A simple and sensitive analytical method development and validation of metformin hydrochloride by RP-HPLC. Int J Pharm Pharm Sci 2011;3(3):117-20.

International Journal of Scientific Research in Science and Technology

Downloads

Published

2018-01-30

Issue

Volume 4, Issue 1, January-February-2018

Section

Research Articles

License

Copyright (c) IJSRST

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

How to Cite

[1]
Faisal A. Shaikh ,Ashish A Gawai, " Method Development and Validation of Stability Indicating RP-HPLC Method for Estimation of Metformin and Miglitol in Pharmaceutical Dosage Form, International Journal of Scientific Research in Science and Technology(IJSRST), Online ISSN : 2395-602X, Print ISSN : 2395-6011, Volume 4, Issue 1, pp.423-442, January-February-2018.