DETERMINATION OF IMPURITY PROFILE OF DRUG SUBSTANCE (API) AND DRUG PRODUCT USING A MODEL DRUG PARACETAMOL
Journal Title:International Journal of Medical Studies
OBJECTIVE: Determination of impurity profile of drug substance (API) and drug product using a model drug paracetamol.
MATERIALS & METHODS: Stock Solution, Paracetamol, HPLC.
RESULTS AND DISCUSSION: Baseline was obtained a straight line, that show proper washing of previous sample. Then chromatogram was obtained with four different retention time of peak with good peak symmetry. Retention time of impurity peak in sample solution, standard solution and spike solution was obtained 7.587, 7.577and 7.687 respectively, Thus results and overlay view of standard and spike chromatograph shows the unknown impurity in the sample represent p−hydroxyacetophenone.
CONCLUSION: The method for the determination of impurity profile using model drug paracetamol was optimized and developed. Two impurity chloroacetyanilide and p−hydroxyacetophenone was found in paracetamol by using optimized condition.
Keywords: Chromatogram, HPLC, Stock solution.