Author(s):
Amitkumar J. Vyas, Nilam M. Visana, Ajay I. Patel, Ashok B. Patel, Nilesh K. Patel, Sunny R. Shah
Email(s):
Visananilam123@gmail.com
DOI:
10.52711/2231-5675.2021.00029 
Address:
Amitkumar J. Vyas1, Nilam M. Visana1*, Ajay I. Patel1, Ashok B. Patel1, Nilesh K. Patel1, Sunny R. Shah2
1Pharmaceutical Quality Assurance Department, B. K. Mody Government Pharmacy College,
Rajkot, Gujarat, India.
2Pharmaceutical Department, B. K. Mody Government Pharmacy Collage, Rajkot, Gujarat, India.
*Corresponding Author
Published In:
Volume - 11,
Issue - 2,
Year - 2021
ABSTRACT:
Analytical methods are required to be developed at different stages of the pharmaceutical product life cycle. The concept of QbD can be extended to analytical method development known as analytical quality by design (AQbD). Quality by design is a systematic approach to development that begins with predefined objects and emphasizes product and process understanding and helps in the systematic approach to drug development. The concepts described in ICH Q8- Q11, commonly referred to as quality by design (QbD), have also been applied to the development of analytical methods. The benefits of applying the QbD principle to analytical methods include identifying and minimizing sources of variability that may lead to poor method robustness and ensuring that the method meets its intended performance requirements throughout the product and method lifecycle. Stress testing is a very important tool in pharmaceutical research and development to predict long-term stability. Stress studies should be performed in stability-indicating method development to understand drug behavior but also can be performed with method validation for regulatory filling predict stability and measure impurities. For determination of degradation pathways and structural elucidation of degradation produced, these stress testing are helpful. It is also used to select the storage condition and improve the manufacturing process of formulations.
Cite this article:
Amitkumar J. Vyas, Nilam M. Visana, Ajay I. Patel, Ashok B. Patel, Nilesh K. Patel, Sunny R. Shah. Analytical Quality by Design in Stress Testing or Stability - Indicating Method. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):170-8. doi: 10.52711/2231-5675.2021.00029
Cite(Electronic):
Amitkumar J. Vyas, Nilam M. Visana, Ajay I. Patel, Ashok B. Patel, Nilesh K. Patel, Sunny R. Shah. Analytical Quality by Design in Stress Testing or Stability - Indicating Method. Asian Journal of Pharmaceutical Analysis. 2021; 11(2):170-8. doi: 10.52711/2231-5675.2021.00029 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2021-11-2-19
REFERENCES:
1. Maapatra A and Meyyanathan SN. Analytical Quality by Design-A review. Indian research journal of pharmacy and science. 2020; 7(2): 2132-2140.
2. Bhvani GP and Devi AD. Development and Validation of Stability Indicating UPLC Method for the Simultaneous Estimation of Drugs in Combined Dosage Forms using Quality by Design Approach. Asian Journal of Pharmaceutical Analysis. 2020; 10(3): 1-19.
3. ICH – Harmonized Tripartite Guideline, “Photo Stability testing of New drug substance and products Q1B”, International Conference on Harmonization, IFPMA, Geneva, Switzerland, 1996;
4. Gaykar D and Khadse SC. A Review on Analytical quality by design. International journal of pharmaceutical science review and research. 2017; 44(2): 96-102.
5. Darkunde SL. A review on quality by design. International journal of pharmaceutical chemistry and analysis.2018, 5(1), 1-6.
6. Jethani JM and Pai GK A. comparative review of the USFDA guidelines on process validation focusing on the importance of quality by design (QbD). Research Journal of Pharmacy and Technology. 2017; 10(4): 1-17.
7. Phadtare DP, Pawar A and Saudagar RB. A Brief Review on Quality by Design and Process Analytical Technology. Asian Journal of Pharmaceutical Analysis. 2016; 6(2): 1-21.
8. Das P and Maity A. Analytical Quality by Design (AQBD): A New Horizon for Robust Analytics in Pharmaceutical Process and Automation. International journal of pharmaceutics and drug analysis. 2017; 5(8): 324-337.
9. Patil KA and Dinkar SF. Determination and Development of UV-Spectrophotometric method for the Amodiquine Hydrochloride by using quality by design (QbD) approach. Asian Journal of Pharmaceutical Analysis. 2019; 9(3): 1-18.
10. Ganorkar AV and Gupta KR. Analytical Quality by Design: A Mini Review. Biomedical journal of scientific and technical research. 2017; 1(6): 1555-1558.
11. Bhutani H and Kurmi M, et.al. Quality by Design (QbD) in Analytical Science: An Overview. Pharma Times. 2014; 46(8): 71-75.
12. Das v, Bhusan B and Saudagar RB. Quality by design approaches to analytical method development. Research Journal of Pharmacy and Technology. 2017; 10(9): 1-21.
13. Peraman R, Bhadraya K and Reddy YP. Analytical Quality by Design: A Tool for Regulatory Flexibility and Robust Analytics. International Journal of Analytical Chemistry. 2015; 1-9.
14. Phadke R, et. al., A review on quality by design approaches to analytical method development. Indo American of pharmaceutical research. 2019; 9(7): 3044-3055.
15. Chavan SD, et. al., Quality by Design. Asian Journal of Research in Pharmaceutical Sciences. 2016; 6(1): 1-19.
16. Tambe K and Bonde S. A review on: Application of pharmaceutical quality by design in product development. Word journal of pharmaceutical science. 2017; 5(1): 58-70.
17. Kadam VR, et. al., A Review on: Quality by Design (QbD). Asian Journal of Research in Pharmaceutical Sciences. 2017; 7(4): 1-20.
18. Pramod K, et al., Pharmaceutical product development: A quality by design approach. International Journal Pharmaceutical Investing. 2016; 6(3): 129-138.
19. Ramalingam P, Kalva B and reddy Y. Analytical Quality by Design: A Tool for Regulatory and Robust Analytics. International Journal of Analytical Chemestry. 2015; 9.
20. Baertschi SW and Reyooldes DW. Pharmaceutical Stress Testing. Taylor and Francis 2005; pp-2.
21. Kumar SA, et.al., Stability indicating Method Development and Validation for simultaneous estimation of Hydrochlorothiazide, Amlodipine and Olmesartan in tablet dosage form by using RP-HPLC. Asian Journal of Research in Chemistry. 2014; 7(5): 1-21.
22. Steven WB and Patrick JJ. Pharmaceutical stress Testing. Taylor and Francis 2005, pp-16.
23. Thakor KA, Bhavsar DD and Thakor JR. International Journal of Research in Pharmacology and Pharmacotherapeutics. International Journal Research Pharmacology and Pharmacotherapeutics. 2016; 5(4): 291-297.
24. Venkataraman S and Manasa M. Forced degradation studies: Regulatory guidance, Characterization of drugs, and their degradation products- a review. 2018; 10(16): 137-143.
25. Sharma MK and Murugesan M. Forced degradation study an essential Approach to Development Stability Indicating Method. Journal of Chromatography Seperation Techniques. 2017; 8(1): 1-3.
26. Deokate U and Gorde AM. Forced Degradation and Stability Testing: Strategies and Analytical Perspectives. International journal Pharmaceutical Science Review and Research. 2014; 26(2): 242-250.
27. Blessy M, et.al., Development of forced degradation and stability indicating studies of drugs- A review. Journal of Pharmaceutical Analysis. 2013; 4(3): 159-165.
28. Basha MD, et.al., A Review on Forced Degradation Studies and Its Importance in Analytical Method Development and Validation. International Journal of Innovative Pharmaceutical Science and Research. 2014; 2(11): 2929-2940.
29. Roge AB et.al., Forced Degradation Study: An Important Tool in Drug Development. Asian Journal of Research in Chemistry. 2014; 7(1): 1-16.
30. Rawat T and Pandy IP. Forced degradation studies for drug substances and drug product –Scientific and Regulatory Considerations. Journal of Pharmaceutical Sciences and Research 2015; 7(5): 238-241.
31. Patel D and Patel M. A Review article on Development of Forced Degradation and stability indicating studies for drug substance and drug product. Journal of Pharmaceutical Science and bioscientific research. 2019; 9(2): 165-172.
32. Hotha KK, et.al., forced degradation studies: practical approach –overview of regulatory guidance and literature for the drug products and drug substances. International research journal of pharmacy. 2013; 4(5): 78-85.
33. Ngwa G. Forced degradation as an integral part of HPLC Stability- Indicating method Development. Drug Delivery Technology. Drug delivery technology. 2010; 10(5): 1-4.
34. Alsante KM, et al., Degradation and Impurity Analysis for Pharmaceutical Drug Candidates. Elsevier Inc. 2011; Pp.60-61.
35. Iram F, et.al., Forced Degradation Studies. Journal of analytical and pharmaceutical research. 2016; 3(6): 1-5.
36. Ghove SB, et.al., Analytical method development and validation by QbD approach-A review. Pelagia research library. 2015; 6(8): 18-24.
37. Reid GL, et.al., Analytical quality by design (AQBD) in pharmaceutical Development. American Pharmaceutical review. 2013; 1-12.
38. Alhakeem MB, et.al., Analytical quality by design with the Life-cycle Approach: A Modern Epitome for Analytical Method Development. Acta Medica Marisiensiensis. 2019; 65(2): 37-44.
39. Kengar MD, Tamboli JA and Magdum CS. Quality by Design in Pharmaceutics. Research Journal of Pharmaceutical Dosage Forms and Technology. 2019; 11(3): 1-16.
40. Goswami S and Chakraverty R. A Review on Application of Quality by Design concept to Analytical Techniques. Internatinal Journal of Current Research In Health And Biological Sciences. 2016; 1(3): 100-108.