Author(s):
Adhao Vaibhav S., Ambhore Jaya P., Thenge Raju R.
Email(s):
adhao.vaibhav@gmail.com , rajuthenge11@gmail.com , jayaambhore02 @gmail.com
DOI:
10.52711/2231-5675.2023.00016 
Address:
Adhao Vaibhav S.*, Ambhore Jaya P., Thenge Raju R.
Dr. Rajendra Gode College of Pharmacy, Malkapur, Maharashtra, India – 443101.
*Corresponding Author
Published In:
Volume - 13,
Issue - 2,
Year - 2023
ABSTRACT:
A new simple, specific, accurate and precise RP-HPLC method was developed for determination of Leflunomide. In the present study, stress testing of Leflunomide was carried out according to ICH guidelines Q1A (R2). Leflunomide was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Effective separation of drug and degradant was achieved was achieved on a Hypersil BDS C18 column (250mm × 4.6mm, 5.0µ particle size) under specific stress conditions using acetonitrile – 0.02M ammonium acetate buffer (60: 40, v/v) as a solvent system with a flow rate of 1.0mL/min. Quantification and linearity was achieved at 260nm over the concentration range of 5-30µg/mL for Leflunomide. The investigated method was validated as per guidelines.
Cite this article:
Adhao Vaibhav S., Ambhore Jaya P., Thenge Raju R. Development and Validation of Stability Indicating High Performance Liquid Chromatography Method for Determination of Leflunomide. Asian Journal of Pharmaceutical Analysis. 2023; 13(2):93-8. doi: 10.52711/2231-5675.2023.00016
Cite(Electronic):
Adhao Vaibhav S., Ambhore Jaya P., Thenge Raju R. Development and Validation of Stability Indicating High Performance Liquid Chromatography Method for Determination of Leflunomide. Asian Journal of Pharmaceutical Analysis. 2023; 13(2):93-8. doi: 10.52711/2231-5675.2023.00016 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-2-5
REFERENCES:
1. Dougados M, Emery P, Lemmel EM, Zerbini CA, Brin S, van Riel PL. When a DMARD fails, should patients switch to sulfasalazine or add sulfasalazine to continuing leflunomide Annals of the rheumatic diseases. 2005 Jan 1; 64(1):44-51.Pinto P, Dougados M. Leflunomide in clinical practice. Acta reumatologic aportuguesa. 2006 Jul 1; 31(3):215-24.
2. Molinaro M, Carazzone C, Barbano D, Abbiati F, Alessiani M, Regazzi M. Assessment of an LC-MS method for plasma quantification of the new immunosuppressant FK778 through comparison with HPLC-UV. In Transplantation proceedings 2005 Jul 1 (Vol. 37, No. 6, pp. 2722-2727).
3. Kher GJ, Ram VR, Dubal KL, Bapodara AH, Joshi HS. Validation of a stability-indicating LC method for assay of leflunomide in tablets and for determination of content uniformity. International Journal of ChemTech Research. 2011; 3(2):523-30.
4. Miron DS, Soldattelli C, Schapoval EE. HPLC with diode-array detection for determination of leflunomide in tablets. Chromatographia. 2006 Mar; 63(5):283-7.
5. Laha TK, Sen S. A Validated Stability Indicating Reversed Phase High Performance Liquid Chromatographic Method of Leflunomide and Characterization of Its Degradation Products through Retro-Synthesis. Journal of Applied Pharmaceutical Science. 2017 May; 7(05):012-7.
6. Sultana N, Arayne MS, Khan MM, Ali SN. Development of liquid chromatography–UV method for simultaneous determination of leflunomide and NSAIDS in API and pharmaceutical formulations: its application to in vitro interaction studies. Med. Chem. 2013; 3(3):262-70.
7. Mallu UR, Venkateswara Rao AN, Kasimala BB. Rapid Stability Indicating HPLC Method for the Analysis of Leflunomide and Its Related Impurities in Bulk Drug and Formulations. Turkish Journal of Pharmaceutical Sciences. 2019 Dec; 16(4):457.
8. Prathyusha Naik CN, Chandra Sekhar KB, Muneer S. A novel stability indicating RP-HPLC method development and validation of leflunomide in bulk and its dosage form. Int J Res Pharm Sci. 2016; 7:47-51.
9. Rao AA, Maheswari IL, Srinubabu G. Development and validation of LC method for the determination of leflunomide in pharmaceutical formulations using an experimental design. African Journal of Pure and Applied Chemistry. 2008 Feb 28; 2(2):010-7.
10. Patel SK, Patel KH, Karkhanis VV, Captain AD. Development and validation of analytical method for estimation of leflunomide in bulk and their pharmaceutical dosage form. Austin J Anal Pharm Chem. 2015; 2(4):1046-56.
11. Lakshmana PS, Suriya PT, Shanmugarathinam A. Development of difference spectrophotometric method for the estimation of leflunomide in tablet dosage form. Chemical Industry and Chemical Engineering Quarterly/CICEQ. 2012; 18(3):407-10.
12. Adhao VS, Thenge RR. Development and validation of stability indicating high performance liquid chromatography method for determination of baclofen. Res. Artic. American Journal of Pharmtech Research. 2017; 7:544-56.
13. Guideline T. Q2A Text on Validation of Analytical Procedures. Fed. Regist. 1994; 60.
14. Adhao VS, Chaudhari SR, Ambhore JP, Sangolkar S, Thenge RR, Cheke RS, Patil AS. Reverse phase-liquid chromatography assisted protocol for simultaneous determination of lamivudine and tenofovir disoproxil fumarate in combined medication used to control HIV infection: an investigative approach. Future Journal of Pharmaceutical Sciences. 2021 Dec; 7(1):1-1.