High performance liquid chromatography (HPLC) is an important analytical tool in analyzing drug stability. HPLC methods should be able to separate, detect, and quantify the various drug-related degradants. Forced degradation studies (chemical and physical stress testing) of new chemical entities and drug products are essential to help develop and demonstrate the specificity of such stability-indicating methods. In addition to demonstrating specificity, forced degradation studies can be used to determine the degradation pathways and degradation products of the APIs that could form during storage, and facilitate formulation development, manufacturing, and packaging. ICH guidelines demonstrate certain degradation conditions like light, oxidation, dry heat, acidic, basic, hydrolysis etc. ICH Q1A, QIB and Q2B exemplify the forced degradation studies. This review overviews the approaches and trends that are used in forced degradation studies.
Cite this article:
Rahul D. Khaire, P. Y. Pawar. A Review on Development of Stability Indicating Analytical Methods for drugs in Bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(4):261-3. doi: 10.52711/2231-5675.2022.00043
Rahul D. Khaire, P. Y. Pawar. A Review on Development of Stability Indicating Analytical Methods for drugs in Bulk and Pharmaceutical Dosage Form. Asian Journal of Pharmaceutical Analysis. 2022; 12(4):261-3. doi: 10.52711/2231-5675.2022.00043 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2022-12-4-8
1. Jain, D.; Basniwal, P. K. Forced Degradation and Impurity Profiling : Recent Trends in Analytical Perspectives. J. Pharm. Biomed. Anal. 2013, 86, 11– 35, DOI: 10.1016/j.jpba.2013.07.013
2. ozet, E.; Lebrun, P.; Debrus, B.; Boulanger, B.; Hubert, P. Design Spaces for Analytical Methods. Trends Anal. Chem. 2013, 42, 157– 167, DOI: 10.1016/j.trac.2012.09.007
3. ICH. Final Concept Paper ICH Q14: Analytical Procedure Development and Revision of Q2(R1) Analytical Validation; ICH, 2018.
4. International conference on harmonization of technical requirements for registration of pharmaceuticals for human use. ICH Harmonised Tripartite Guideline, Validation of Analytical Procedures: Text and Methodology Q2(R1); ICH, 2005.
5. Faizan Dosani, Nawaz Hakam, Aman Vyawahare, Swanand Patharkar, Kalpak Gajbhiye. Development and Validation of Stability Indicating Method of UV-Spectrophotometry for the Estimation of Flavoxate in Bulk and Tablet Dosage form. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):6-2. doi: 10.52711/2231-5675.2022.00002.
6. Manda Pravalika, Jorige Archana. A New Validated Spectroscopic Method for the estimation of Sodium Benzoate in Soft drinks. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):13-6. doi: 10.52711/2231-5675.2022.00003
7. Vinod Ahirrao, Rajiv Jadhav, Kiran More, Rahul Kale, Vipul Rane, Jaydeo Kilbile, Mohammad Rafeeq, Ravindra Yeole. An Accurate and Precise Analytical Method for Estimation of Active Sulfur Trioxide and Sulfuric acid in Triethylamine Sulfur Trioxide Complex. Asian J. Pharm. Ana. 2022; 12(1):17-2. doi: 10.52711/2231-5675.2022.00004.
8. Jyoti Sonawane, Sonali Rathod, Sonali Suryawanshi, Durgesh Kale, Chaudhari Amit. Development and Validation of RP-HPLC Method for Estimation of Lacosamide in Bulk and Its Pharmaceutical Formulation. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):23-8. doi: 10.52711/2231-5675.2022.00005.
9. D. D. Masne, R. D. Chakole, M. S. Charde. QbD Approached in Method Development, Validation and Degradation Profiling of Aripiprazole a Antidepressent Agent. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):29-4. doi: 10.52711/2231-5675.2022.00006.
10. A. Suneetha, B. Chandra Sekhar, K. Sudheer Babu. DOE Assisted RP-HPLC Method Development and Validation for Estimation of L-Cysteine and Cystine with Dansyl Chloride derivatization in Presence of Amino Acid Mixture. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):35-2. doi: 10.52711/2231-5675.2022.00007.
11. Ceema Mathew, Sunayana Varma. Green Analytical Methods based on Chemometrics and UV spectroscopy for the simultaneous estimation of Empagliflozin and Linagliptin. Asian Journal of Pharmaceutical Analysis. 2022; 12(1):43-8. doi: 10.52711/2231-5675.2022.0000.
12. Hamid Khan. Analytical Method Development in Pharmaceutical Research: Steps involved in HPLC Method Development. Asian J. Pharm. Res. 2017; 7(3): 203-207.
13. Anand Gupta, Vaishali Jadhav, Ashish Jain. Analytical Method Development and Validation of Ticagrelor from Bulk and Formulation. Asian J. Pharm. Res. 2019; 9(3):141-146.
14. Sonali Mahaparale, Diksha Banju. Recent Analytical Methods of Anti-Helmintic Agents. Asian J. Pharm. Res. 2019; 9(3):209-218.