Development and Validation of Analytical Method for Simultaneous Estimation of Formoterol Fumarate Dihydrate and Fluticasone Propionate from Bulk and Dry Powder Inhaler Formulation

  • Rahul K Godge Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni tal. Rahata dist. Ahemadnagar, India
  • Soniya S Satpute Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni tal. Rahata dist. Ahemadnagar, India
  • Magar M Sagar Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni tal. Rahata dist. Ahemadnagar, India

Abstract

A method was developed and validated for analysis of Formoterol Fumarate and Fluticasone Propionate in dry powder inhaler formulations. Separation was achieved on a HiQ Sil C18HS, 250×4.6 mm, 5 µm column using a mobile phase consisting of Acetonitrile: 0.01 M Ammonium Dihydrogen Phosphate solution (80:20 %v/v) at a flow rate of 1ml/min PDA detection at 215.0 nm. This method is validated according to ICH guidelines, which include linearity, precision, accuracy, specificity, robustness. The result obtained were within the acceptance criteria as per ICH guidelines.


Keywords: formoterol fumarate dihydrate, fluticasone propionate, buffer, HPLC.

Downloads

Download data is not yet available.

Author Biographies

Rahul K Godge, Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni tal. Rahata dist. Ahemadnagar, India

Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni tal. Rahata dist. Ahemadnagar, India

Soniya S Satpute, Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni tal. Rahata dist. Ahemadnagar, India

Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni tal. Rahata dist. Ahemadnagar, India

Magar M Sagar, Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni tal. Rahata dist. Ahemadnagar, India

Department of Pharmaceutical Chemistry, Pravara Rural College of Pharmacy, Loni tal. Rahata dist. Ahemadnagar, India

References

1. Christen GD, Analytical Chemistry. Fifth edition, John Wiley and Sons, 2003, 35-42, 131-132.
2. Mendham J, Denney RC, Barnes JD, Thomas M.Vogel’s Textbook of Quantitative Analysis. Pearson Education, Singapore, 2003, 8-9.
3. ICH, Q2 (R1). Validation of analytical procedures: text and methodology, International Conference on Harmonization, Geneva, 2005, 1- 13.
4. FDA, International Conference on Harmonization: Draft Revised Guidance on Q1A(R) Stability Testing of New Drug Substances and Products, 2000 Federal Register 65 (78), 21446–21453[ICH Q1A(R)].
5. Rang, HP, Dale MM, Ritter JM Flower, R. J. Pharmacology, 6th edition, Published by Churchill Livingstone Elsevier, 2007, 363-366 .
6. Indian Pharmacopoeia, Vol. II, Govt. of India, Ministry of Health and Family Welfare. New Delhi Published by The Controller of Publications, 2007, 1142, 1144.
7. British Pharmacopoeia, Vol. I, Published by The Stationery Office on behalf of Medicines & Healthcare Products Regulatory Agency(MHRA), 2009, 904-906, 913-915.
8. Martindale,The complete drug reference, publishesd by pharmaceutical press, 34rth edition, 2005, 786.1, 1102.3.
9. Lemke L, Williams DA, Roche VF, Zito SW, Foye’s Principles of Medicinal Chemistry, 6th edition, Published by Lipincott Williams & Wilkins, 2008, 900-901.
10. Munson JW, Pharmaceutical Analysis, Modern methods-Part B, International Medical book Distributors. Mumbai, 2001, 51-54.
11. Sharma BK Instrumental Methods of Chemical Analysis, 25thedition, Goel Publication Co. Meerut, 1983, 3- 6.
12. Skoog DA, Holler FJ, Crouch SR. Principle of Instrumental Analysis, 6th edition, Thomson Publications, India, 2007, 1-3, 145-147, 180.
13. Chatwal, GR. Sharma A. Instrumental Methods of Chemical Analysis, 5th edition, Himalaya Publishing House, Delhi, 2004, 1.1-1.5.
14. The Merck Index, 13th edition, Published by Merck Research Laboratories, Division of Merck & Co, INC Whitehouse station, NJ, 746(4237),753(4269).
15. Willard HH, Jr. Merritt LL, Dean JA, Jr. Settle, FA Instrumental Methods of Analysis, 7th edition, CBS Publishers and Distributors, Delhi, 2001, 1-4.
16. Sethi PD, High Performance Liquid Chromatography, Quantitative Analysis of Pharmaceutical Formulations, 1st edition, CBS Publishers and Distributors, New Delhi, 2001, 3-11, 116-120.
Statistics
51 Views | 90 Downloads
How to Cite
Godge, R. K., Satpute, S. S., & Sagar, M. M. (2019). Development and Validation of Analytical Method for Simultaneous Estimation of Formoterol Fumarate Dihydrate and Fluticasone Propionate from Bulk and Dry Powder Inhaler Formulation. Journal of Drug Delivery and Therapeutics, 9(3-s), 212-222. https://doi.org/10.22270/jddt.v9i3-s.2827