G. K. Dyade, Bhushankumar Arve, Chaitanya Nimbalkar
G. K. Dyade, Bhushankumar Arve, Chaitanya Nimbalkar
Dept of Post Graduate in Pharmaceutical Quality Assurance, SVPM’S College of Pharmacy, Malegaon (BKII) Baramati Dist Pune, Maharashtra, India.
Volume - 12,
Issue - 2,
Year - 2022
Quality by design (QbD) is a systematic process for pharmaceutical development recommended by regulatory agencies like USFDA. Development of various pharmaceutical processes including analytical methods by applying Quality by design aids in ensuring the robustness of the method. An analytical method was developed for the estimation of fluvastatin by applying QbD approach by UV-VIS spectrophotometry. Solvent 0.1 N NaOH was utilised and 302.4 nm was the wavelength for measurement of absorbance. Effect of input variables on spectrum characteristics were studied for selection of critical parameters and developed method was validated as per ICH Q 2 R1 regulatory guidelines. Linearity of the drugs was ascertained over the conc range 5-40 mcg/ml (microgram/ml). The accuracy was found within acceptable limit with SD 0.05079-0.78188 %; and the precision study was shown acceptable data as % RSD 0.6259-0.6559 for FVT. The stability of the method was studied by minor variation in the wavelength and minor change in the normality of solvent. The developed method is rigid, robust and efficient for the estimation of FVT from the dosage form. QbD was applied to build rigid robust method through risk assessment at early stage and defining the design space at the later stage. The analytical methods, developed based on the QbD concept are more robust and reduce the number of out of trend (OOT) and out of specification (OOS) results during the actual usage in quality control.
Cite this article:
G. K. Dyade, Bhushankumar Arve, Chaitanya Nimbalkar. Implementation of QBD Approach in Analytical Method Development of Fluvastatin by UV-VIS Spectrophotometry. Asian Journal of Pharmaceutical Analysis. 2022; 12(2):87-3. doi: 10.52711/2231-5675.2022.00016
G. K. Dyade, Bhushankumar Arve, Chaitanya Nimbalkar. Implementation of QBD Approach in Analytical Method Development of Fluvastatin by UV-VIS Spectrophotometry. Asian Journal of Pharmaceutical Analysis. 2022; 12(2):87-3. doi: 10.52711/2231-5675.2022.00016 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-2-4
1. Alison Brayfield. Martindale (The complete drug reference). 39th ed. Pharmaceutical press London UK. 2017(A). P. A A1414.
2. John M. Beale, Jr. John H. Block. Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical chemistry. 12th ed. Wolters Kluwer (India) Pvt Ltd New Delhi. 2016.p. 653.
3. The Merck Index. An Encyclopaedia of chemicals, drugs and Biological. 15th ed. the Royal Society of Chemistry Cambridge UK. 2013. p. 774.
4. Thomas L. Lemke, David A. Williams, Victoria F Roche, S William Zito. Foyes principles of medicinal chemistry. 7th ed (4Th Indian Reprint), Wolters Kluwer (India) Pvt Ltd New Delhi.2018. p. 827.
5. Mariusz Stolarczyk, Anna Maślanka, Anna Apola, Wojciech Rybak, Jan Krzek. Derivative spectrophotometric method for simultaneous determination of Zofenopril and fluvastatin in mixtures and pharmaceutical dosage forms. Spectrochimica acta Part A: Molecular and Biomolecular Spectroscopy. 2015, (148), 66-71.
6. Jahnavi Bandla, Nameera Jabeen, Ashok Gorja. Development and validation of First-order derivative UV spectrophotometric method for the determination of Fluvastatin sodium in formulation. International Journal of Pharmaceutical sciences and research. 2021, 12(12), 6721-6724.
7. Sukhbir Singh, Neelam Sharma, Naha Kanojia, Gurpreet Kaur, Sandeep Arora. Development and validation of UV spectrophotometric method for analysis of fluvastatin sodium in PEG 6000 and PVPK 30 solid dispersions. Plant Archieves. 2020, 20(1), 3365-3371.
8. Saminathan J, Sankar A S, Anandakumar K, Vetrichelvan T. Simple UV spectrophotometric method for the determination of the fluvastatin sodium in bulk and pharmaceutical formulations. Journal of chemistry. 2009, 6(4), 1233-1239.
9. Erk. N. Rapid spectrophotometric method for quantitative determination of simvastatin and fluvastatin in human serum and pharmaceutical formulations. Die Pharmazie. 2002, 57(12), 817-819.
10. Yan JL, Lu XP. Determination of Fluvastatin sodium by differential pulse voltammetry. Journal of Chinese clinical medicine. 2006, 1(1), 33-36.
11. Amira Louiza Assassi, Claude-Eric Roy, Philippe Perovitch, Jack Auzerie, Karen Gaudin. Green analytical method development for statin analysis. Journal of Chromatography A. 2015, (1380), 104-111.
12. Heli Sirén, Laura Kaijanen, Sini Kaartinen, Monna Väre, Eeva Jernström. Determination of statins by gas chromatography- EI/MRM- Tandem mass spectrometry: Fermentation of pine samples with Pleurotus ostreatus. Journal of Pharmaceutical and Biomedical Analysis. 2014, (94), 196-202.
13. Saikh M. Wabaidur, Zeid A. AlOthman, Masoom R. Siddiqui, Kazi Mohsin, George A. Karikas. UPLC-MS method for the simultaneous determination of naproxen, fluvastatin and ibuprofen in waste water samples. Journal of Industrial and Engineering Chemistry. 2015, (24), 302-307.
14. Gomes F P, Garcia P L, Alves J M P, Singh A K, et al. Development and validation of stability indicating HPLC method for quantitative determination of pravastatin fluvastatin and rosuvastatin in pharmaceuticals. Analytical Letters. 2009, 42(12), 1784-1804.
15. Julia Martín, Wolfgang Buchberger, Esteban Alonso, Markus Himmelsbach, Irene Aparicio. Comparison of different extraction methods for the determination of statin drugs in wastewater and river water by HPLC/Q-TOF-MS. Talanta. 2011, 85(1), 607-615.
16. Di Pietro G, Coelho E B, Geleilete T M,Marques M P, et al. Chiral evaluation of fluvastatin in human plasma by HPLC electrospray mass spectrometry. Journal of chromatography-B: Analytical technologies in bio medical and life sciences. 2006, 832(2), 256-261.
17. British Pharmacopoeia. Medicines and Healthcare products regulatory agency London; 2019. pp.I-156, II-1048.
18. Indian Pharmacopoeia, Govt. of India, ministry of Health and family welfare, The Indian pharmacopoeia commission Ghaziabad. 8th ed (II, III). 2018; pp.1045, 3319.
19. ICH Expert working group. ICH Harmonized tripartite Guideline-Pharmaceutical development Q 8 R2. In current step 4 version. 2009; p. 1-28.
20. ICH Expert working group. ICH harmonized tripartite Guideline-Quality Risk Management Q 9. In current step 4 version.. 2005; p. 1-23.
21. ICH Expert working group. ICH Harmonized tripartite Guideline-Pharmaceutical Quality system Q 10. In current step 4Th version. 2008; p. 1-21.
22. ICH Expert working group. ICH Harmonized tripartite Guideline-Validation of analytical procedures: Text and methodology Q 2 R1. In current step 4 version. 2005; p. 1-17.
23. Vedantika Das, Bhushan Bhairav, R. B. Saudagar. Quality by Design approaches to Analytical Method Development. Research Journal of Pharmacy and Technology. 2017; 10(9): 3188-94.
24. Yogita M. Kolekar. Understanding of DoE and its advantages in Pharmaceutical development as per QbD Approach. Asian Journal of Pharmacy and Technology. 2019; 9 (4):271-75.
25. Vrushali R. Kadam, M. P. Patil, Vrushali V. Pawar, Sanjay Kshirsagar. A Review on: Quality by Design (QbD). Asian Journal of Research in Pharmaceutical Sciences. 2017; 7(4):197-204.
26. Aditee Mishal, Sudha Rathod. Quality by Design: A New Era of Development of Quality in Pharmaceuticals. Research Journal of Pharmacy and Technology. 2014; 7(5): 581-91.
27. Schweitzer M, Pohl M, Hanna-Brown M, Nethercote P, Bormanare P, Hansen G, et al. Implications and opportunities of applying QbD principles to analytical measurements. Pharm Technology. 2010; 34: 12-29.
28. Vogt F G, Kord A S. Development of quality-by-design analytical methods. Journal of Pharmaceutical science. 2011; 100:797-812.
29. Bhatt D A, Rane S I. QbD approach to analytical RP-HPLC method development and its validation, International Journal of Pharmaceutical Science. 2011; 3:179-187.
30. 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 Journal Pharmacy and Technology. 2017; 10(4): 1257-1260.
31. Jaydeep S Chauhan, Ritika Gajre. Analytical method development and validation for Estimation of Calcium Dobesilate and Docusate Sodium in Pharmaceutical dosage form with QbD approach. Research Journal of Pharmaceutical Dosage Forms and Technology. 2021; 13(3):213-9.
32. Noopur K. Gandhi, Sindhu B. Ezhava. Stability indicating Analytical Method Development using Quality by Design (QbD) approach for simultaneous estimation of Ivabradine and Metoprolol. Research Journal of Pharmacy and Technology. 2021; 14(11):5937-4.
33. Dyade G. K., Sawant R. L., Joshi H. A., Shinde A. D., Bandal R. S., Gadhingleskar S. V. A Novel Approach: Effect of polarity Index of mobile phase on Retention Time of Antihyperlipidemic Antihypertensive and Angiotensin inhibiting Drugs in RP-HPLC Method. Research Journal of Pharmacy and Technology. 2020; 13(7): 3065-3071.
34. Senthil Prabhu R, Mohamed Asraf Ali S, Vijayalakshmi S, Abdul Hasan Sathali A. Formulation and Evaluation of pH Sensitive Mucoadhesive Microspheres of Fluvastatin Sodium. Research Journal of Pharmacy and Technology. 8(10): Oct., 2015; Page 1343-1352.
35. M A Hakeem Siddiqui, Roshan S. Pharmacokinetic Drug Interactions between HMG-COA Reductase Inhibitors Fluvastatin with Concomitantly administered Ticagrelor. Research Journal of Pharmacy and Technology. 2018; 11(1): 179-182