Development and Validation of a Stability-Indicating RP-HPLC and UV Spectrophotometric Methods for the ESTİMATİON of Fluindione in Bulk and Tablet Dosage Forms
More details
Hide details
Research & Development, Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University, Kakinada. Andhra Pradesh, India
Department of Pharmaceutical Analysis and Quality Assurance, University College of Pharmaceutical Sciences, Andhra University, Visakhapatnam, Andhra Pradesh, India
N. Mallikarjuna Rao   

Research & Development, Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological University, Kakinada. Andhra Pradesh, India
Publication date: 2017-10-05
Eurasian J Anal Chem 2015;10(2):127–136
Fluindione is an oral anticoagulant. The aim of the present study was to develop a stability-indicating HPLC and UV Spectrophotometric methods for the determination of fluindione in bulk and its solid dosage forms. HPLC method was developed on a Symmetry (4.6 x 150 mm, 5 μm, Make: ODS) column with a mobile phase consisting of sodium phosphate buffer pH 3.5: acetonitrile 50:50 v/v, pumped at 1.0 ml min-1 flow rate. The pH of buffer was adjusted to 3.5 with ortho phosphoric acid. The column was maintained at ambient temperature and 20μL of solutions were injected. The analyte was quantified spectrophotometrically at 285 nm. Fluindione eluted at 3.5 min. The method was validated reaching satisfactory results for selectivity, precision and accuracy. Forced degradation samples could be simultaneously evaluated, without interferences in the quantitative analysis. For the spectrophotometric analysis, methanol was used as solvent and the wavelength of 285 nm was selected for the detection. Both methods were found to quantify fluindione in bulk and its tablets accurately. Statistical analysis by Student's t-test showed no significant difference between the results obtained by the two methods. Therefore HPLC and UV methods presented the most reliable results for the analyses of fluindione tablets.
Kearon C, Kahn SR, Agnelli G, Goldhaber S, Raskob GE, Comerota AJ (2008) Antithrombotic therapy for venous thromboembolic disease. Chest: 133(6_suppl): 454S-545S. doi:10.1378/chest.08-0658.
Holford N (1986) Clinical pharmacokinetics and pharmacodynamics of warfarin. Understanding the dose- effect relationship. Clinical Pharmacokinetics. 11(6): 483–504. 483-504.
Fourel I, Hugnet C, Goy-Thollot I, Berny P (2010) Validation of a New Liquid Chromatography– Tandem Mass Spectrometry Ion-Trap Technique for the.
Simultaneous Determination of Thirteen Anticoagulant Rodenticides, Drugs or.
Natural Products. Journal of Analytical Toxicology. 34(2): 95-102.
Lotfi H, Dreyfuss MF, Marquet P, Debord J, Merle L, Lachatre G (1996) A Screening Procedure for the Determination of 13 Oral Anticoagulants and Rodenticides. Journal of Analytical Toxicology, Vol. 20 (2): 93-100.
Aymard G, Legrand M, Comets E, Mentre F, Diquet B (1998) Rapid and simple micro method for the quantification of fluindione in human plasma using high-performance liquid chromatography. Journal of Chromatography B: Biomedical Applications 707 (1-2): 169-17.
Saravanan D, Satheesh B (2014) Simultaneous quantification of aspirin and fluindione in tablet formulation. Research Journal of Chemistry and Environment, 18 (4): 78-82.
Thimmaraju K, Hemant K, Swarnalatha P, Vinayakumar J, Kasagoni S (2015).
Development and validation of UV spectrophotometric method for fluindione Manish. Scholars Research Library Der Pharmacia Lettre. 7 (2): 237-242.
International Conference on Harmonization Guideline on Validation of Analytical Procedures (2005) Text and Methodology: Q2 (R1).
International Conference on Harmonization Guideline on Stability Testing of New Drug Substances and Products (2003) Q1 A (R2).