Stability Indicating Hptlc Method For The Estimation Of Quercetin

  • M. Mandhanya, R. Choukse, R. Patel


The stability - indicating assay is a method that is employed for the analysis of stability samples in
pharmaceutical industry. It is essential to validate an assay with regards to its precision, accuracy,
reproducibility, selectivity and robustness. The current guidelines available for stability testing of
drug substances and products requires the conduct of stress testing or forced degradation studies for
performing stability indicating assays but none of the guidelines specify how these studies emphasize
that the testing of those features which are susceptible to change during storage and are likely to
influence quality; safety and/or efficacy must be done by validated stability indicating testing
methods. Stability indicating analytical methods well established for active pharmaceutical ingredient
and thus the allopathic medicine can be tested for it quality standards with respect to the degradation
of the products. Thus, considering the need for development of stability indicating analytical methods
for herbal medicine the objective of this study is as follows: To apply the developed and validated
HPTLC method for biomarkers namely; for the detection of forced degradation products Quercetin.