Author(s): Amitkumar J. Vyas, Chirag D. Jadav, Ajay I. Patel, Ashok B. Patel, Sunny R. Shah, Devang Sheth, Sandip Dholakia

Email(s): rxchiragjadav@gmail.com

DOI: 10.52711/2231-5675.2023.00022   

Address: Amitkumar J. Vyas1, Chirag D. Jadav1*, Ajay I. Patel1, Ashok B. Patel2, Sunny R. Shah1, Devang Sheth3, Sandip Dholakia3
1B. K. Mody Government Pharmacy College, Rajkot - 360003, Gujarat, India.
2Government Pharmacy College, Gandhinagar - 382027, Gujarat, India.
3L.M. College of Pharmacy, Ahmedabad - 380009, Gujarat, India.
*Corresponding Author

Published In:   Volume - 13,      Issue - 2,     Year - 2023


ABSTRACT:
Stability-indicating methods are crucial analytical techniques that aim to evaluate the stability of a drug substance or product over time. They are designed to detect any alterations in the drug's chemical, physical, or biological characteristics that may occur during storage, transportation, and usage. These modifications can significantly impact the drug's safety and effectiveness, making stability testing an integral part of pharmaceutical quality control. The stability-indicating methods are used to identify the degradation products of a drug, quantify the rate of degradation, and determine the factors that may contribute to degradation. These conditions can include exposure to light, heat, humidity, and various chemical and physical stressors. The methods can be chromatographic or spectrophotometric and undergo validation to ensure their reliability, accuracy, and specificity for the specific drug. The acceptable level of degradation in forced degradation studies should not exceed 5-30% of the total active ingredient present in the drug substance or product. This helps to ensure that the results obtained are trustworthy and can be used to make informed decisions about the stability of the drug.


Cite this article:
Amitkumar J. Vyas, Chirag D. Jadav, Ajay I. Patel, Ashok B. Patel, Sunny R. Shah, Devang Sheth, Sandip Dholakia. Review on Stability Indicating Assay Method or Forced Degradation Study: Strategy and Regulatory Consideration. Asian Journal of Pharmaceutical Analysis. 2023; 13(2):131-9. doi: 10.52711/2231-5675.2023.00022

Cite(Electronic):
Amitkumar J. Vyas, Chirag D. Jadav, Ajay I. Patel, Ashok B. Patel, Sunny R. Shah, Devang Sheth, Sandip Dholakia. Review on Stability Indicating Assay Method or Forced Degradation Study: Strategy and Regulatory Consideration. Asian Journal of Pharmaceutical Analysis. 2023; 13(2):131-9. doi: 10.52711/2231-5675.2023.00022   Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-2-11


REFERENCES:
1.    ICH. International Conference on Harmonization (ICH). Guidance for industry: Q1A(R2) Stability testing of new drug substances and products. ICH Harmon Tripart Guidel. 2003; 4(February):24.
2.    Rathod N, Prajapati PAI. Analytical Method Development and Validation of Stability Indicating Method and Related Substance by Using RP-HPLC of Drug Substance. J Pharm Anal. 2018; 8(5):367–72.
3.    Vyas AJ, Visana NM, Patel AI, Patel AB, Patel NK, Shah SR. Analytical quality by design in stress testing or stability-indicating method. Asian J Pharm Anal. 2021; 11(2):170–8.
4.    Patel AB, Asnani AH, Vyas AJ, Patel NK, Patel AI, Lumbhani AN. A Brief Review on Genotoxic impurities in Pharmaceuticals. Asian J Pharm Res. 2021 [cited 2023 Feb 16]; 11(3):187–93
5.    B. Patel A, K. Jinja B, Kumar J. Vyas A, K. Patel N, I. Patel A, B. Sheth D, et al. A Retrospective Study of Warning letters Issued by US FDA Over 2019-2021. Asian J Pharm Res. 2022; (483):295–301.
6.    Patel AB, Bundheliya AR, Vyas AJ, Patel NK, Patel AI, Lumbhani AN. A review on metal impurities in pharmaceuticals. Asian J Pharm Anal. 2021; 11(3):212–22.
7.    Ajay I. Patel, Krupa B.Prajapati, Amit J. Vyas, Ashok B. Patel, Nilesh K. Patel. Determination and validation of phthalate impurities in milk by uv-spectrophotometry method. Monitor PS. 2019; 10(4):49–58.
8.    Rajput M, Patel N, Chotaliya U, Patel A, Patel A, Vyas A. Determination of genotoxic impurity by chromatographic method. Pharma Sci Monit. 2017; 8(2):24–31.
9.    Vyas AJ, Patel SM, Patel AB, Patel AI, Patel NK, Shah S, et al. Stability testing: An Essential study for Vaccine Formulation Development. Asian J Pharm Res. 2022; 12(1):29–36.
10.    Vyas AJ, Gol DA, Patel AI, Patel AB, Patel NK, Chavda JR, et al. Implementing analytical quality by design (AQbD) approach for simultaneous estimation of tadalafil and macitentan by RP-HPLC asian. Anal Chem Lett. 2021; 11(4):539–52.
11.    Patel AI, Prajapati KB, Jolapara SH, Vyas AJ, Patel AB, Patel NK, et al. RP-HPLC method for determination of Gemfibrozil using central composite design (CCD). Res J Pharm Technol. 2021; 14(6):3009–14.
12.    Shinde NG, Bangar BN, Deshmukh SM, Sulake SP, Sherekar DP. Pharmaceutical Forced Degradation Studies with Regulatory Consideration. Asian J Res Pharm Sci. 2013; 3(4):178–88.
13.    Singh Chauhan Y, Nex R, Sevak G, Singh Rathore M. Stability Testing of Pharmaceutical Products. Res J Pharm Dos Forms Technol. 2021; 13(04):317–28.
14.    Roge AB, Tarte PS, Kumare MM, Shendarkar GR, Vadvalkar SM. Forced Degradation Study: An Important Tool in Drug Development. Pharm Res. 2013; 3(January):99–102.
15.    Sutar S V., Yeligar VC, Patil SS. A review: Stability indicating forced degradation studies. Res J Pharm Technol. 2019; 12(2):885–90.
16.    Sherawat R, Maithani M, Singh R, Regulatory aspects in development of stability indicating method: A review. Chromatographia 2010; 72:1-6
17.    Analytical procedures and methods validation for drugs and biologics guidance for industry. Fda.gov. 2015
18.    Szepesi G, Gazdag M, Mihályfi K. Selection of high-performance liquid chromatographic methods in pharmaceutical analysis. III. Method validation. J Chromatogr. 1989; 464(2):265–78.
19.    Carr GP, Wahlich JC. A practical approach to method validation in pharmaceutical analysis. J Pharm Biomed Anal. 1990; 8(8–12):613–8.
20.    Jenke DR. Chromatographic method validation: A review of current practices and procedures. I. general concepts and guidelines. J Liq Chromatogr Relat Technol. 1996; 19(5):719–36.
21.    International Conference on Harmonization. Q3B (R2): Impurities in New Drug Products. London, UK: European Medicines Agency; 2003; 68(220):64628–64629
22.    FDA, Guidelines for Submitting Documentation for Stability of Human Drugs and Biologics Food and Drug Administration, Rockville 1998.
23.    Guidance for Industry: Submitting Documentation for the Stability of Human Drugs and Biologics Food and Drug Administration, Rockville, 1987.
24.    Guidance for Industry (Draft): Stability Testing of Drug Substances and Drug products Food and Drug Administration, Rockville, 1998.
25.    Michael Kats. Forced Degradation Studies: Regulatory Considerations and Implementation. BioPharm International, 2005: 1-08
26.    Hovorka S, Schöneich C. Oxidative degradation of pharmaceuticals: theory, mechanisms and inhibition. J Pharm Sci. 2001; 90(3):253–69.
27.    Anderson NH, Johnston D, McLelland MA, Munden P. Photostability testing of drug substances and drug products in UK pharmaceutical laboratories. J Pharm Biomed Anal. 1991; 9(6):443–9.
28.    Bakshi M, Singh S., Development of Validated StabilityIndicating Assay Methods: Critical Review. J. Pharm. Biomed. Anal. 28; 2002: 1011–1040
29.    Singh S, Bakshi M. Guidance on conduct of stress tests to determine inherent stability of drugs. Phrama Tech 24, 2000: 1- 14.
30.    Skoog, DA, West DM. Principles of Instrumental Analysis. Saunderg Golden, Japan. 1980: 2-3.
31.    Brummer H., How to approach a forced degradation study. Life science technical bulletin issue. 2011: 3.
32.    Alsante KM, Martin L, Baertschi SW., A Stress Testing Benchmarking Study. Pharm. Technol. 27 (2); 2003: 60–72
33.    Baertschi SW, Thatcher SR. Sample presentation for photostability studies: problems and solutions, pp: 445, In; Pharmaceutical Photostability and Stabilization Technology. Piechocki J, Editor, Taylor & Francis, New York. 2006.
34.    ICH Harmonised Tripartite Guideline Q2 (R1), Validation of Analytical Procedures: Text and Methodology, November 2005.
35.    Patel JR, Joshi HV, Shah UA, Patel JK. A Review on Computational Software Tools for Drug Design and Discovery. Indo Global J. Pharm. Sci. 2022 Jan. 29; 12:53-81.
36.    Clarke CJ, Tu W-C, Levers O, Bröhl A, Hallett JP. Green and sustainable solvents in chemical processes. Chem Rev. 2018; 118(2):747–800.
37.    Singh AK, Bilal M, Iqbal HMN, Raj A. In silico analytical toolset for predictive degradation and toxicity of hazardous pollutants in water sources. Chemosphere. 2022; 292:133-250.
38.    Baertschi SW, Pack BW, Hoaglund Hyzer CS, Nussbaum MA. Assessing mass balance in pharmaceutical drug products: new insights into an old topic. Trends Analyt Chem. 2013; 49:126–36.

Recomonded Articles:

Author(s): Asha M. Jagtap, Sudhir R. Kaulage, Shivam S. Kanse, Vishal D. Shelke, Akshata S. Gavade, Ganesh B. Vambhurkar, Rohit R. Todkar, Vidya N. Dange

DOI: 10.5958/2231-5675.2018.00035.2         Access: Open Access Read More

Author(s): Sushil D. Patil, Sunil V. Amurutkar, C.D. Upasani

DOI: 10.5958/2231-5675.2016.00030.2         Access: Open Access Read More

Author(s): Dipti G. Phadtare, Pawar Amol R, R.B. Saudagar

DOI: 10.5958/2231-5675.2016.00019.3         Access: Closed Access Read More

Author(s): Pankaj Bhamare, Rupal Dubey, Neeraj Upmanyu, Pothuvan Umadoss

DOI: 10.5958/2231-5675.2021.00001.6         Access: Open Access Read More

Author(s): Hamid Khan, Javed Ali

DOI: 10.5958/2231-5675.2017.00020.5         Access: Open Access Read More

Author(s): K. Pramod, Shahid H. Ansari, Javed Ali

DOI:         Access: Open Access Read More

Author(s): G. Krishnamoorthy, C. Diana Priyadarshini, R. Senthamarai

DOI:         Access: Open Access Read More

Author(s): Shobha Rani G, Lohita M, Jaya Preethi P, Madhavi R, Sunisitha B, Mounika D

DOI:         Access: Open Access Read More

Author(s): Sushil D. Patil, Sayali K. Chaure, Maswood Ahmed Hafizur Rahman, Prajkta U. Varpe, Sanjay Kshirsagar.

DOI: 10.5958/2231-5675.2017.00004.7         Access: Open Access Read More

Author(s): Yogita R. Indalkar, Aloorkar N.H.

DOI: 10.5958/2231-5675.2015.00028.9         Access: Open Access Read More

Asian Journal of Pharmaceutical Analysis (AJPA) is an international, peer-reviewed journal, devoted to pharmaceutical analysis...... Read more >>>

RNI: Not Available                     
DOI: 10.5958/2231–5675 


Recent Articles




Tags