The accurate, fast, cost effective and robust RP- HPLC chromatographic method was developed and validated by using Quality by Design approach as per the ICH guidelines, for Linearity, Accuracy, Interday-Intraday Precision, Specificity and Selectivity, Robustness, Solution stability. The Design of Experiment was carried out by using 3 level factorial designs using design expert software. Change in pH and Mobile Phase concentration is considered for design of experiment. Based on the results obtained from screening of various mobile phase Acetonitrile as to Water having proportion 50:50 at 4 pH and Maximum Wavelength 315nm were selected for the analysis of Dasatinib by employing QbD methodology. The HPLC method is more sensitive, accurate and precise compared to the previously reported method. There was no interference of excipients in the recovery study. The low value of %RSD, molar extinction coefficient (L mol-1 cm-1) suggested that the developed method is sensitive. The proposed high-performance liquid chromatographic method proved to be convenient simple, cost effective and effective for the quality control of Dasatinib.
Cite this article:
Jayendrasingh P. Bayas, M. Sumithra. Analytical Method Development and Validation of Dasatinib in Bulk and Pharmaceutical Formulation using Quality by Design. Research J. Pharm. and Tech 2021; 14(3):1591-1596. doi: 10.5958/0974-360X.2021.00282.1
Jayendrasingh P. Bayas, M. Sumithra. Analytical Method Development and Validation of Dasatinib in Bulk and Pharmaceutical Formulation using Quality by Design. Research J. Pharm. and Tech 2021; 14(3):1591-1596. doi: 10.5958/0974-360X.2021.00282.1 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-3-71
1. “ICHQ8 Quality guidance: Pharmaceutical Development”.
2. “ICHQ9 Quality guidance: Quality Risk Management”.
3. “ICHQ10Quality guidance: Pharmaceutical Quality System”.
4. “ICHQ11Quality guidance: Development and Manufacture of Drug Substance”.
5. Raman NV, Mallu UR, Bapatu HR. Analytical quality by design approach to test method development and validation in drug substance manufacturing. Journal of Chemistry. 2015;2015.
7. Sandhu PS, Beg S, Katare OP, Singh B. QbD-driven development and validation of a HPLC method for estimation of tamoxifen citrate with improved performance. Journal of Chromatographic Science. 2016 Sep 1;54(8):1373-84.
8. Mhaske DV, Dhaneshwar SR. Stability indicating HPTLC and LC determination of dasatinib in pharmaceutical dosage form. Chromatographia. 2007 Jul 1;66(1-2):95-102.
9. Roche S, McMahon G, Clynes M, O’Connor R. Development of a high-performance liquid chromatographic–mass spectrometric method for the determination of cellular levels of the tyrosine kinase inhibitors lapatinib and dasatinib. Journal of Chromatography B. 2009 Dec 1;877(31):3982-90.
10. Kassem MG, Ezzeldin E, Korashy HM, Mostafa GA. High-performance liquid chromatographic method for the determination of dasatinib in rabbit plasma using fluorescence detection and its application to a pharmacokinetic study. Journal of Chromatography B. 2013 Nov 15;939:73-9.
11. Ramachandra B, Naidu NV, Sekhar CK. Validation of RP-HPLC method for estimation of dasatinib in bulk and its pharmaceutical dosage forms. International Journal of Pharmacy and Biological Sciences. 2014; 4(1):61-8.
12. Phale MD, Hamrapurkar PD. A validated and simplified RP-HPLC of metoprolol succinate from bulk drugs. Asian Journal of Research in Chemistry. 2009; 2(2):119-22.
13. Raju GV, Ganapathy S, Sankar DG, Naidu PY. RP-HPLC Determination of Levetiracetam in Bulk and Pharmaceutical Formulation. Asian Journal of Research in Chemistry. 2009; 2(3): 253-7.
14. NR Vekariya, GF Patel, Rohit B Dholakiya. Determination of Telmisartan in Solid Dosage Form by RP-HPLC. Asian J. Research Chem. 2009; 2(4): 506-508.
15. Y Rajendraprasad, KK Rajasekhar, V Shankarananth, S Bharath Kumar, G Dileep Kumar, T Sreelekha. RP-HPLC Method for the Estimation of Domperidone in Bulk and Pharmaceutical Formulations. Asian J. Research Chem. 2009; 2(4): 561-564.
16. K Ananda kumar, G Kumaraswamy, T Ayyappan, ASK Sankar, D Nagavalli. Validated RP-HPLC Method for the Estimation of Eszopiclone in Bulk and Tablet Dosage Form. Asian J. Research Chem. 2010; 3(1): 63-66.
17. K.S. Nataraj, P. Sivalingachari, S. Sai Naveen, K. Alekhya. Method Development and Validation for the Estimation of Dasatinib Monohydrate Tablets by RP-HPLC. Asian J. Research Chem. 2013; 6(9): 859-862.
18. Jay M Jetani, Girish Pai K. A Comparative Review of the USFDA Guidelines on Process Validation Focusing on the Importance of Quality by Design (QbD). Research J. Pharm. and Tech. 2017; 10(4): 1257-1260.
19. Vedantika Das, Bhushan Bhairav, R. B. Saudagar. Quality by Design approaches to Analytical Method Development. Research J. Pharm. and Tech. 2017; 10(9): 3188-3194.
20. Dipti G. Phadtare, Pawar Amol R, R.B. Saudagar. A Brief Review on Quality by Design and Process Analytical Technology. Asian J. Pharm. Ana. 2016; 6(2): 122-130.
21. Patil Karishma Ashok, Firke Sandip Dinkar. Determination and Development of UV-Spectrophotometric method for the Amodiquine Hydrochloride by using quality by design (QBD) approach. Asian J. Pharm. Ana. 2019; 9(3):113-117.