Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Review Article Volume 4 Issue 9

Hyphenated Techniques, an Important Tool for Force Degradation Study

Rushikesh Shirgaonkar, Aniket Lomate and Sachin A Pishawikar*

Department of Pharmaceutical Quality Assurance, Bharati Vidyapeeth College of Pharmacy, Navi Mumbai, Maharashtra, India

*Corresponding Author: Sachin A Pishawikar, Department of Pharmaceutical Quality Assurance, Bharati Vidyapeeth College of Pharmacy, Navi Mumbai, Maharashtra, India.

Received: July 22, 2020; Published: August 27, 2020

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Abstract

The pharma market is getting flooded with many new drug formulations as well as fixed dose combination formulations in which different API are there. Each of this is going to contain different types of impurities as well as they are bound to undergo process of degradation by different mechanisms leading to formation of degradation products. All of these are going to be present as impurities. Though the impurities will be within limit in accordance to regulatory authorities, still in case of disease like diabetes and hyper tension the patient is going to be on medicine for rest of his life hence bound to get over exposure to these. Some of which may cause adverse effects like cytotoxic and genotoxic. Hence indeed there is need for identification. In previous era it was ok with regulatory authorities if components in formulation were 99% pure. But know they are insisting on identification of that remaining 1%.

Though there is challenge in front of analytical chemists, use of sophisticated instruments for analysis of impurities has increased and has made task little easier. Scientist are working towards discovering different types of methods whereby accurate results can be obtained. Hyphenated techniques have received tremendous attention as it is been seen as the principal means to solve complex analytical problems. The combined power of separation techniques like chromatography in combination with spectroscopic techniques has been predominantly used over the years for both quantitative and qualitative analysis of unknown compounds. The hyphenated techniques have provided analytical chemist a tool to come over the challenge associated with impurity profiling and determination of safety and efficacy of API. Among all hyphenated techniques, the most exploited techniques for impurity profiling of drugs are Liquid Chromatography (LC)-Mass Spectroscopy (MS), LC-NMR, LC-NMR-MS, GC-MS and LC-MS. This reveals the need and scope of impurity profiling of drugs in pharmaceutical research.

Keywords: Liquid Chromatography (LC); Mass Spectroscopy (MS); Hyphenated Techniques; Force Degradation

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References

  1. Yoshioka S and Stella VJ. “Stability of drugs and dosage forms”. Kluwer Academic Publisher: New York (2002).
  2. Carstensen JT and Rhodes CT. “Drug Stability Principles and Practices”. Marcel Dekker: New York (2000).
  3. International Conference on Harmonization, ICH Q1A (R2), Stability Testing of New Drug Substances and Products, Geneva (2003).
  4. International Conference on Harmonization, ICH Q1B, Photo stability testing of new drug substances and products, Geneva (1996).
  5. FDA, Guidance for Industry: Stability Testing of Drug Substances and Drug Products. Rockville, MD (1998).
  6. WHO Guidelines for stability testing of Active Pharmaceutical Ingredients and finished pharmaceutical products (2009).
  7. Branch SK. “Guidelines from the International Conference on Harmonization”. Journal of Pharmaceutical and Biomedical Analysis 38.5 (2005): 798-805.
  8. Singh S and Bakshi M. “Development of stability-indicating assay methods”. Journal of Pharmaceutical and Biomedical Analysis 28.6 (2002): 1011-1040.
  9. Singh S and Bakshi M. “Guidance on conduct of stress tests to determine inherent stability of drugs”. Pharmaceutical Technology 24 (2000): 1-14.
  10. Rourick RA., et al. “Predictive strategy for the rapid structure elucidation of drug degradants”. Journal of Pharmaceutical and Biomedical Analysis 14.12 (1996): 1743-1752.
  11. Reynolds DW. “Available guidance and best practices for conducting forced degradation studies”. Pharmaceutical Technology 26.2 (2002): 48-56.
  12. Alsante KM., et al. “A stress testing benchmarking study”. Pharmaceutical Technology 27.2 (2003): 60-72.
  13. Khan H., et al. “Stability testing of pharmaceutical products: Comparison of stability testing guidelines”. Current Pharmaceutical Analysis 6.2 (2010): 140-148.
  14. Khan H., et al. “Validated UPLC/Q-TOF-MS method for simultaneous determination of aceclofenac, paracetamol, and their degradation products in tablets”. Journal of Liquid Chromatography and Related Technologies 35.1 (2012): 109-128.
  15. International Conference on Harmonization, ICH Q3A (R2), Impurities in New Drug Substances, Geneva (2003).
  16. International Conference on Harmonization, ICH Q3B (R2), Impurities in New Drug Products, Geneva, (2003).
  17. Ahuja S. “Impurities evaluation of pharmaceuticals”. Marcel Dekker, New York (2006).
  18. Qiua F and Norwood DL. “Identification of pharmaceutical impurities”. Journal of Liquid Chromatography and Related Technologies 30.5 (2007): 877-935.
  19. Roy J. “Pharmaceutical impurities- A review”. AAPS PharmSciTech 3.2 (2002): 1-8.
  20. Rahman N., et al. “Importance of impurity analysis in pharmaceutical products”. Accreditation and Quality Assurance 11.2 (2006): 69-74.
  21. Dong MW., et al. “Liquid chromatographic considerations for high sensitivity impurity and stability testing of pharmaceuticals”. Journal of Liquid Chromatography and Related Technologies 13.11 (1990): 2135-2160.
  22. Wong AW and Datla A. In Hand Book of Pharmaceutical Analysis by HPLC, Ahuja S, Dong MW, Edition. Elsevier Academic Press: San Diego (2005): 335-358.
  23. Ahuja S and Scypinski S. “Hand Book of Modern Pharmaceutical Analysis”. Harcourt Science and Technology: San Diego (2001).
  24. Lee H. “Pharmaceutical applications of liquid chromatography coupled with mass spectrometry (LC/MS)”. Journal of Liquid Chromatography and Related Technologies 28.7 (2005): 1161-1202.
  25. Lee H., et al. “Identification and control of impurities for drug substance development using LC/MS and GC/MS”. Journal of Liquid Chromatography and Related Technologies 31.15 (2008): 2235-2252.
  26. Vyas VK., et al. “Recent advances in characterization of impurities-Use of hyphenated LC-MS technique”. Current Pharmaceutical Analysis 6.4 (2010): 299-306.
  27. Ravi Sankar S. Text Book of Pharmaceutical Analysis, Rx Publications: India (2001).
  28. Swartz ME. “UPLC: An Introduction and Review”. Journal of Liquid Chromatography and Related Technologies 28.1 (2005): 1253-1263.
  29. Novakova L., et al. “Advantages of application of UPLC in pharmaceutical analysis”. Talanta 68.3 (2006): 908-918.
  30. Plumb R., et al. “Ultra performance liquid chromatography coupled to quadrupole-orthogonal time-of-flight mass spectrometry”. Rapid Communications in Mass Spectrometry 18.19 (2004): 2331-2337.
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Citation

Citation: Sachin A Pishawikar., et al. “Hyphenated Techniques, an Important Tool for Force Degradation Study". Acta Scientific Pharmaceutical Sciences 4.9 (2020): 23-28.




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