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  • Development And Validation Of HPLC Method For Estimation Of Fluoxetine HCL In Bulk And Pharmaceutical Dosage Form
  • 1Department of Pharmaceutical Quality Assurance, R.G. Sapkal College of Pharmacy, Anjanery, Nashik
    2Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjanery, Nashik
    3Department of Pharmacology, R.G. Sapkal College of Pharmacy, Anjanery, Nashik

Abstract

A simple, sensitive and accurate RP-HPLC method has been developed for the determination of Fluoxetine HCL in bulk and marketed formulation. The method was developed after the several trials at the composition of Methanol: water (70:30), flow rate 1.0 ml/min and 264 nm wavelength of detection and retention time is 4.8 min. The method shows high sensitivity with linearity 5-25 µg/ml (regression equation: y = 203134x + 9713.5; r2 = 0.9997). The various parameters according to ICH guidelines and USP are followed for validating and testing of this method. The Detection limit and quantitation limit were found to be 0.008 µg ml–1 and 0.02 µg ml–1 respectively. The results demonstrated that the procedure is accurate, specific and reproducible (RSD <2%), and also being simple, cheap and less time consuming and appropriate for the determination of Fluoxetine HCL in bulk and Table dosage form.

Keywords

Fluoxetine HCL, HPLC method, Method development, Validation

Reference

  1. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q2_R1/Step4/Q2_R1 Guideline.pdf
  2. Validation of Compendial Procedures, United State Pharmacopeia, USP 36 NF, 27 (2) (2010).
  3. Kenkel J., Analytical Chemistry for Technicians, Third Edition, 2009, Published by CRC Publication, 2-4.
  4. V. Gupta, A.D. K. Jain, N.S. Gill, K. Gupta, Development and validation of HPLC method - a review , Int. Res J Pharm. App Sci., 2(4) (2012) 17-25
  5. M.S. Azim, M. Mitra, P.S. Bhasin, HPLC method development and validation: A review, Int. Res. J. Pharm. 4(4) (2013) 39-46.
  6. Kasture A.V., Mahadik  K. R., Wadodkar S. G., More H. N., Pharmaceutical Analysis, Vol.II, Seventh Edition, 2007, Nirali Publication, 28-30.
  7. Jeffery G. H., Bassett J., Mendham J., Denny R. C., Vogel’s Textbook of Quantitative chemical Analysis, Fifth Edition, 1991, Longman Scientific and Technical Publishers, 3-13.
  8. Chatwal G. R., Anand S. K., Instrumental Methods of Chemical Analysis, Fifth Edition, 2008, Himalaya Publishing House, 2.108-2.124.
  9.  Pavia D. L., Lampman G. M., Kriz G. S., Introduction to Spectroscopy,  Third Edition, Thomson Learning publication, 356, 797-817.
  10. M.W. Dong, Modern Hplc for practicing scientists, John Wiley & Sons, New Jersey, 2006
  11. Beckett A. H., Stenlake J. B., Practical Pharmaceutical Chemistry, Fourth Edition Part II, 2004, CBS Publishers and distributors, 284-300,162-163.
  12. Furnis B. S., Vogel’s Textbook of practical organic chemistry. Longman group UK Ltd 5th Edition Edition, 1989, UK, 384-386.
  13. B. Prathap, G.H.S. Rao, G. Devdass, A. Dey, N. Harikrishnan , Review on Stability Indicating HPLC Method Development, International Journal of Innovative Pharmaceutical Research.3(3) (2012) 229237.
  14. Rashmin  M.,  An  introduction  to  analytical  method  development  for pharmaceutical formulations. pharmainfo.net; 2008; 6 (4); 1-11.
  15. Rathee P, Rathee S, Thakur S, Kumar V (2010) Simultaneous estimation of Amlodipine besylate and Atenolol as API and in tablet dosage forms by vierodt’s method using UV spectrophotometry, IJCTR 2(1); 62-68.
  16. Beebe Path are, Vrushali Tambe, Shashikant Dhole, Vandana Patil; An update on various analytical techniques based on UV spectroscopy used in determination of dissociation constant; IJP 2014; 4(1): 278-285.
  17. Jasmine  Choudhary,  Akash  Jain,  Vipin  saini;  Simultaneous  estimation  of multicomponent formulations by UV-Visible spectroscopy: A review; IRJP 2011, 2(12), 81-83.
  18. Dipali   M   Atole,   Hrishikesh   H   Rajput;   Ultraviolet   Spectroscopy   and   Its Pharmaceutical Applications- A Brief Review; AJPCR, 2018, Vol. 11(2), 59-66.
  19. Kalpesh  N  Patel,  Jayvadan  K.  Patel,  Ganesh  C.  Rajput,  Naresh  B.  Rajgor; Derivative spectrometry method for chemical analysis: A review; Der Pharmacia Lettre, 2010, 2(2): 139-150.
  20. Tiwari  G,  Tiwari  R,  Srivastava  B,  Rai  A,  Pathak  K  (2008)  Simultaneous estimation of Metronidazole and Amoxicillin in synthetic mixture by ultraviolet spectroscopy. AJRC;1(2): 91-94.
  21. Hayam   M.   Lotfy,   Sarah   S.   Saleh;   Recent   Development   in   Ultraviolet Spectrophotometry through the Last Decade (2006–2016): A Review; IJPPS 2016, 8(10), 40-56.
  22. Willard HH, Merritt LL, Settle FA, Instrumental methods of analysis., 7th Edition, 1996, CBS publishers and distributors Pvt. Ltd., New Delhi, 118-148, 598-607.
  23. Skoog D. A., Holler F. J., Crouch S. R., Principles of Instrumental Analysis, Sixth Edition, (2007), Thomson Brook Publishers, 848-850.
  24. Snyder L., Kirkland J., Practical HPLC Method Development. Wiley Intersciences a John Wiley & Sons publication: 1997, 2-68.
  25. Sharma B. K., Instrumental methods of chemical analysis, Twenty Sixth Edition 2008, GOEL publishing house, Meerut; C80-C82.
  26. T. Bhagyasree, N. Injeti, A. Azhakesan, U.M.V. Rao, A review on analytical method development and validation,International Journal of Pharmaceutical Research & Analysis, Vol 4 (8) (2014) 444-448.
  27. Swadesh J. K., HPLC Practical and industrial Applications, Second edition, CRC press, 10, 11,146-150.
  28. Ahmad Jamshidi, Hamid Mobedi, Stability-indicating HPTLC assay for Fluoxetine HCL, JPC - Journal of Planar Chromatography - Modern TLC, 19(109), 223-227.
  29. Mahmoud A. Tantawy, Simultaneous determination of olanzapine and fluoxetine hydrochloride in capsules by spectrophotometry, TLC-spectrodensitometry and HPLC, Journal of Advanced Research, Volume 4, Issue 2, March 2013, Pages 173-180
  30. Avisek Mukhopadhyay, Kishanta Kumar Pradhan, Development And Validation Of An Uv- Spectrophotometric Method For The Estimation Of Fluoxetine In Pure And Tablet Dosage Forms, Ijpsr, 2014; Vol. 5(8): 3418-3424..
  31. Syed Ayaz Ali, Sonali Nerkar, Determination of Fluoxetine and Zonisamide by UV Spectrophotometric method, Journal of Medicinal Chemistry and Drug Discovery, 2015, 438-444
  32. Rubesh kumar S, P Gayathri, Simultaneous Estimation of Fluoxetine HCl and Olanzapine in Bulk Drug and Pharmaceutical Formulation by Using UV-Visible Spectroscopy Method, International Journal of Pharmaceutical Sciences and Drug Research 2011; 3(1): 52-55.
  33. Jasmin Shah, Muhammad Rasul Jan, Quantitative Determination of Fluoxetine in Pharmaceuticals and Plasma Samples Using Bromatometric Method, American Journal of Analytical Chemistry, 2012, 3, 828-835.
  34. Ross Birch, Kathryn Lawson-Wood, HPLC Analysis of Fluoxetine Hydrochloride Using a Quasar C8 Column in Accordance with the United States Pharmacopeia, PerkinElmer, Inc.
  35. Anwar A Wassel and Heba El-agezy, Development and Validation of (HPLC) Method for Simultaneous Determination of Atomoxetine HCl & Fluoxetine HCl in their Pharmaceutical Dosage Forms, Biomed J Sci & Tech Res 34(4)-2021. BJSTR. MS.ID.005582.
  36. Reena Paghadal, Mayank Bapna, Development and validation of analytical method for estimation of fluoxetine hydrochloride in oral solution, Journal of Chemical and Pharmaceutical Research, 2014, 6(6):1166-1172.
  37. E Bueno, A.M.Bergold, Assay of fluoxetine hydrochloride by titrimetric and HPLC methods, Bollettino chimico farmaceutico. 139. 256-9.
  38. Sejal patel and n. J. Patel, Simultaneous RP-HPLC and HPTLC Estimation of Fluoxetine Hydrochloride and Olanzapine in Tablet Dosage Forms, Indian J. Pharm. Sci., 2009, 71 (4): 477-480.
  39. Suzan Mahmoud Soliman, Heba MY El-Agizy, Validated Stability -Indicating UPLC Method for Determination of Dapoxetine and Fluoxetine: Characterization of Their Hydrolytic Degradation Products, Kinetic Study and Application in Pharmaceutical Dosage Forms, Soliman et al., Pharm Anal Acta 2017, 8:12.
  40. Available from: https://go.drugbank.com/drugs/DB00472
  41. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Fluoxetine

Photo
Sanket Hire
Corresponding author

Department of Pharmaceutical Quality Assurance, R.G. Sapkal College of Pharmacy, Anjanery, Nashik

Photo
Smita Aher
Co-author

Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjanery, Nashik

Photo
Rushikesh Bachhav
Co-author

Department of Pharmacology, R.G. Sapkal College of Pharmacy, Anjanery, Nashik

Sanket Hire*, Smita Aher, Rushikesh Bachhav, Development And Validation Of HPLC Method For Estimation Of Fluoxetine HCL In Bulk And Pharmaceutical Dosage Form, Int. J. in Pharm. Sci., 2023, Vol 1, Issue 11, 81-90. https://doi.org/10.5281/zenodo.10065688

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