How can the GC or HPLC method is selected to determine the impurity profile in drug product?
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Answer Posted / Nisar Ahmad
The selection of Gas Chromatography (GC) or High-Performance Liquid Chromatography (HPLC) for determining the impurity profile in a drug product depends on various factors such as sample solubility, volatility, and stability. Here are some general guidelines:
1. GC is typically used for volatile, thermally stable compounds with low molecular weight.
2. HPLC is suitable for non-volatile, labile compounds with high molecular weight or those that are not easily vaporized.
3. If the sample requires derivatization to increase its volatility, GC might be a better choice.
4. When analyzing biomolecules like peptides and proteins, HPLC is often preferred due to its higher selectivity and lower risk of degradation.
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