E-ISSN 2063-5346
 

Research Article 


ANALYTICAL QUALITY BY DESIGN APPROACH IN RPHPLC METHOD DEVELOPMENT FOR THE ASSAY OF TERIFLUNOMIDE IN BIOLOGICAL SAMPLES

K.Rohith Chandra, Aswathy V.S, Jyothi Krishna. P, Arun KP.

Abstract
A reversed-phase high-performance liquid chromatography (RP-HPLC) method has been developed using an ODSC18
column for the analysis of teriflunomide (TRF), in accordance with the regulatory requirement of Analytical Quality by Design
(AQbD) in the development of robust analytics. Following risk analysis, a number of critical method variables (CMV) were used
as inputs, including the solvent modifier (A), flow rate (B), injection volume (C), column tem (D), and buffer strength (E), while
the corresponding Flow rate (F1), injection volume (F2), and buffer strength (F3) of TRF were used as method responses that are
likely to have an impact on method performance. The analytical target profile (ATP) was established in accordance with ICH and
USP standards. The Central Composite Design (CCD) and Fractional-Factorial Design(FFD) was used as a tool in the
investigation of scientific understanding between input variables (A-E) and method responses (F1-F3). The method operable
design region (MODR) was arrived at by subsequent analysis of systematic simulation followed by 3D-Contour plots. There were
Five candidate methods were selected within MODR and verified experimentally. The r2 value was 0.997 (TRF) indicating the
consistency of the model and reliability of the method in the region. Among the methods, a method Solvent modifierACN:0.1AA(A), the Flow rate of 0.75 µM/ml (B), Injection volume of 15 µL/ml (C) Column temp of 27°C (D) and Buffer
strength of 50 µM (E) was validated as per ICH Q2R1 guidelines. A conventional RP- HPLC method was developed by trialand-error method and was compared with the AQbD method. The result indicated the AQbD method was relatively more robust
with CMV range ofACN-0.1AA (A), 0.5-1.0(B), 10-20 (C), 25-30(D)and 50-30(E) whilst the conventional HPLC method failed
for robustness.

Key words: AQbD, Teriflunomide, RP-HPLC, Method Development


 
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How to Cite this Article
Pubmed Style

K.Rohith Chandra, Aswathy V.S, Jyothi Krishna. P, Arun KP. ANALYTICAL QUALITY BY DESIGN APPROACH IN RPHPLC METHOD DEVELOPMENT FOR THE ASSAY OF TERIFLUNOMIDE IN BIOLOGICAL SAMPLES. ECB. 2022; 11(5): 44-52. doi:10.31838/ecb/2022.11.05.007


Web Style

K.Rohith Chandra, Aswathy V.S, Jyothi Krishna. P, Arun KP. ANALYTICAL QUALITY BY DESIGN APPROACH IN RPHPLC METHOD DEVELOPMENT FOR THE ASSAY OF TERIFLUNOMIDE IN BIOLOGICAL SAMPLES. https://www.eurchembull.com/?mno=105223 [Access: September 25, 2022]. doi:10.31838/ecb/2022.11.05.007


AMA (American Medical Association) Style

K.Rohith Chandra, Aswathy V.S, Jyothi Krishna. P, Arun KP. ANALYTICAL QUALITY BY DESIGN APPROACH IN RPHPLC METHOD DEVELOPMENT FOR THE ASSAY OF TERIFLUNOMIDE IN BIOLOGICAL SAMPLES. ECB. 2022; 11(5): 44-52. doi:10.31838/ecb/2022.11.05.007



Vancouver/ICMJE Style

K.Rohith Chandra, Aswathy V.S, Jyothi Krishna. P, Arun KP. ANALYTICAL QUALITY BY DESIGN APPROACH IN RPHPLC METHOD DEVELOPMENT FOR THE ASSAY OF TERIFLUNOMIDE IN BIOLOGICAL SAMPLES. ECB. (2022), [cited September 25, 2022]; 11(5): 44-52. doi:10.31838/ecb/2022.11.05.007



Harvard Style

K.Rohith Chandra, Aswathy V.S, Jyothi Krishna. P, Arun KP (2022) ANALYTICAL QUALITY BY DESIGN APPROACH IN RPHPLC METHOD DEVELOPMENT FOR THE ASSAY OF TERIFLUNOMIDE IN BIOLOGICAL SAMPLES. ECB, 11 (5), 44-52. doi:10.31838/ecb/2022.11.05.007



Turabian Style

K.Rohith Chandra, Aswathy V.S, Jyothi Krishna. P, Arun KP. 2022. ANALYTICAL QUALITY BY DESIGN APPROACH IN RPHPLC METHOD DEVELOPMENT FOR THE ASSAY OF TERIFLUNOMIDE IN BIOLOGICAL SAMPLES. European Chemical Bulletin, 11 (5), 44-52. doi:10.31838/ecb/2022.11.05.007



Chicago Style

K.Rohith Chandra, Aswathy V.S, Jyothi Krishna. P, Arun KP. "ANALYTICAL QUALITY BY DESIGN APPROACH IN RPHPLC METHOD DEVELOPMENT FOR THE ASSAY OF TERIFLUNOMIDE IN BIOLOGICAL SAMPLES." European Chemical Bulletin 11 (2022), 44-52. doi:10.31838/ecb/2022.11.05.007



MLA (The Modern Language Association) Style

K.Rohith Chandra, Aswathy V.S, Jyothi Krishna. P, Arun KP. "ANALYTICAL QUALITY BY DESIGN APPROACH IN RPHPLC METHOD DEVELOPMENT FOR THE ASSAY OF TERIFLUNOMIDE IN BIOLOGICAL SAMPLES." European Chemical Bulletin 11.5 (2022), 44-52. Print. doi:10.31838/ecb/2022.11.05.007



APA (American Psychological Association) Style

K.Rohith Chandra, Aswathy V.S, Jyothi Krishna. P, Arun KP (2022) ANALYTICAL QUALITY BY DESIGN APPROACH IN RPHPLC METHOD DEVELOPMENT FOR THE ASSAY OF TERIFLUNOMIDE IN BIOLOGICAL SAMPLES. European Chemical Bulletin, 11 (5), 44-52. doi:10.31838/ecb/2022.11.05.007