Principles of analytical chemistry to drug analysis &Stability Indicating Assay Method (SIAM)

Authors

  • Vishal N. Kushare  Department of Pharmaceutics, Maratha Vidya Prasarak Samaja’s Institute of Pharmaceutical Sciences, Adgaon, Nashik, Maharastra, India
  • Sagar V. Ghotekar  Department of Pharmaceutics, SSDJ College of Pharmacy Chandwad,Nashik, Maharashtra, India

Keywords:

ICH, Qualitative Analysis, formulation, Stability Indicating

Abstract

Pharmaceutical analysis is the integral part of the pharmaceutical sciences. Pharmaceutical analysis is the application of principles of analytical chemistry to drug analysis. The stability of the active component is a major criterion in determining the suitability of the dosage form. The Stability-Indicating Assay Method (SIAM) is a quantitative analytical procedure used to detect a decrease in the amount of the active pharmaceutical ingredient (API) present due to degradation. International Conference on Harmonization (ICH) Guidelines has made mandatory the requirement of SIAM. Stability is defined as the capacity of a drug substance or a drug product to remain within specifications established to ensure its identity, strength, quality, and purity throughout the retest period or expiration dating period. According to ICH, the guidance is provided to design of stability studies for drug substances and drug products that should result in a statistically acceptable level of confidence for the established retest or expiration dating period for the formulation. An elaborate definition of stability-indicating methodology is, however, provided in the United States-Food and Drug Administration (US-FDA) stability guideline of 1987 and the draft guideline of 1998.

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International Journal of Scientific Research in Chemistry

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Published

2020-08-30

Issue

Volume 5, Issue 4, July-August-2020

Section

Research Articles

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How to Cite

[1]
Vishal N. Kushare, Sagar V. Ghotekar, " Principles of analytical chemistry to drug analysis &Stability Indicating Assay Method (SIAM), International Journal of Scientific Research in Chemistry(IJSRCH), ISSN : 2456-8457, Volume 5, Issue 4, pp.24-28, July-August-2020.