What is it about?
A simple, accurate, precise, rapid, economic stability indicating HPLC analytical method has been developed and validated for routine as well as control sample analysis of AMD-ATR combination solid dosage form. The results from forced degradation studies show that the method is selective and stability indicating, i.e. its ability to separate these drugs, and its impurities from their degradation products, related impurities, excipients found in tablet dosage form and hence could apply for the analysis of samples placed for stability study as per ICH guidelines.
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Why is it important?
This is significant, because of having a unique quality of determining assay and impurities in a single method.
Perspectives
In this method, we can able to determine the assay as well as its impurities in a single method. Here, five atorvastatin impurities and one amlodipine impurity addressed. So, it is a single economic method for the determination of both assay and impurities of Amlodipine/Atorvastatin combination dosage form by RP-HPLC.
Mr Manoj Kumar Vadlamudi
VIT University
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This page is a summary of: Stability-indicating method for the determination of assay and quantification of impurities in amlodipine–atorvastatin combination dosage form by RP-HPLC, Journal of Liquid Chromatography & Related Technologies, June 2017, Taylor & Francis,
DOI: 10.1080/10826076.2017.1334215.
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