Quality by Design Assisted Analytical Reverse-phase High Performance Liquid Chromatography Method Development and Validation for the estimation of Glasdegib
Abstract
The present work aims to develop and validate a simple, accurate and robust RP-HPLC method for the estimation of Glasdegib by using Analytical Quality by Design (AQbD) approach. Design of experiments was applied for multivariate optimization of reverse-phase high performance liquid chromatography
(RP-HPLC) method. The critical method parameters were systematically optimized using Box-Behnken design (BBD). Design Expert® (11.1.0.1) modeling software (Stat-Ease Inc., Minneapolis, MN, USA) was used to generate 2D Contour and 3D Surface plots. Chromatographic separation was accomplished on Kromasil 100 C18 (250×4.6 mm, 5 μm) column at 300C. The optimized and predicted data from Design Expert software consisted of mobile phase phosphate buffer pH 4.4 and Acetonitrile (51.8:49.2 %v/v), pumped at a flow rate of 0.98mL /min gave the desirability function of 1. The UV detector was set at 225nm. The developed method was linear with a correlation coefficient of 0.9992. The optimized chromatographic method was validated as per ICH Q2 (R1) guidelines for system suitability, specificity, linearity, accuracy, precision, limit of detection (LoD), and limit of quantitation (LoQ). The drug's stability was examined under different stress conditions forcibly and significant degradation was found in 20% H2O2.
Keywords:
AQbD, BBD, RP-HPLC, Glasdegib, Forced degradationDOI
https://doi.org/10.25004/IJPSDR.2021.130107References
Cortes JE. Survival outcomes and clinical benefit in patients with acute myeloid leukemia treated with glasdegib and low-dose cytarabine according to response to therapy. J Hematol Oncol 2020; 13: 92.
Riddle RD, Johnson RL, Laufer E, Tabin C. Sonic hedgehog mediates the polarizing activity of the ZPA. Cell. 1993; 75(7): 1401- 1416.
DAURISMOTM (glasdegib) Prescribing Information. New York. NY: Pfizer Inc: 2018.
Sravani S, Anusha P, Tarakeswari Bai B. Stability indicating assay method development and validation Of Glasdegib by RP-HPLC. J emerg technol. 2020 Feb; 7(2):333-338.
Cortes JE, Heidel FH, Hellmann A, Fielder W, Smith BD, Robak T et al. Randomized comparison of low dose cytarabine with or without glasdegib in patients with newly diagnosed acute myeloid leukemia or high-risk myelodysplastic syndrome. Leukemia. 2019; 33:379-389.
Lam JL, Vaz A, Hee B, Liang Y, Yank X, Navved Shaik M. Metabolism, excretion and pharmacokinetics of [14C] Glasdegib (PF-04449913) in healthy volunteers following oral administration. Xenobiotica 2016; 47(12): 1064-1076.
Prafulla Kumar S, Nageswara Rao R, Teresa C, Suryakanta S, Chandra Sekhar P, Jagadeesh P. An overview of Experimental designs in HPLC Method development and validation. J Pharm Biomed Anal. 2018; 147:590-611.
Deepa M, Ravindra Reddy K, Satyanarayana S V. A Review on Quality by design approach for analytical method development. J Pharm Res. 2017; 11(4); 272-277.
Box GEP, Behnken DW. Some new 3 level designs for the study of quantitative variables. Technometrics 1960; 2: 455-75.
ICH. Q2 (R1): Guidelines on validation of analytical procedure: Text and methodology. 2005.
Blessy M, Ruchi Patel D, Prajesh Prajapati N, Agarwal YK. Development of forced degradation and stability indicating studies of drugs- A review. J Pharm Anal. 2014; 4(3):159-165.
Montgomery DC. Design and analysis of experiments. 7th edition New York: John Wiley and Sons: 2008.
Lewis GA, Mathieu D, Phan-Tan-Luu R. Pharmaceutical experimental design. 1st edition New York: Marcel Dekker; 1999.
Fukuda IM, Fidelis Pinto CF, Santos Moreria CD, Saviano AM, Lourenco FR. Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD). Braz J Pharm Sci. 2018; 54 (Special).
Singh S, Singla YP, Arora S. Statistical, Diagnostic and Response surface analysis of Nefopam Hydrochloride Nanospheres using 35 Box-Behnken design. Int J Pharm Pharm Sci. 2015; 7(10): 89-101.
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