Impurity Profiling And Stress Degradation Study On Nicergoline | 18748
Journal of Analytical & Bioanalytical Techniques
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Impurities are either naturally occurring or added during synthesis of a chemical or commercial product. During production,
impurities may be purposely, accidentally, inevitably, or incidentally added into the substance. Any impurities present drug
substances can be addressed in its chemical and safety perspectives. 5 Bromo Nicoticnic Acid (5BNA) is basically a reactant
impurity present in the Nicergoline (NCR). The present study aims to develop simple, sensitive, precise method to estimate
the 5BNA impurity and perform the stress degradation study in NCR to screen the NCR stability in different stress conditions
by using HPLC. The developed method was used as 25 mM phosphate buffer:acetonitrile as a mobile phase (50:50% v/v)
with flow rate of 1 mL/min. Limit of detection and quantification were found out to be 1.15 and 3.5 ng/ml respectively. The
method was liner over the range of 0.3-1.1 μg/ml. The forced degradation study described the nicergoline drug shows markable
degradation in acid and alkali hydrolysis but it does not shows significant changes in chromatographic pattern. In case of
the photo stability and oxidative degradation shows significant changes in the chromatogram. The new fractions apart from
5-bromo nicotinic acid were subjected to NMR structural analysis. The develop method can be useful to estimate the impurity
in bulk drug and formulations. The developed method was validated as per ICH guidelines. The developed method has shown
good repeatability and reproducibility.
M R Jeyaprakash is working as a faculty member in the Department of Pharmaceutical Analysis, JSS College of Pharmacy, Udhagamandalam, The Nilgiris, India
from 1st Sep 2007 to till date. The author is perusing the Doctor of Philosophy under impurity profiling and genotoxicity area. He graduated from AK College of
Pharmacy, Srivilliputhur, Tamilnadu, India.
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