ABSTRACT:
Background: Quality by Design is an organized approach to developing products or methods that starts with predetermined goals and progresses to understanding the product and method through science and risk management techniques, finally leading to method control. Attaining measurable quality is the goal of analytical QbD. A review of the literature on Ferrous fumarate reveals that neither its bulk nor the pharmaceutical dose form have been subjected to any analytical methods that could determine its stability. Objective: In order to quantify Ferrous fumarate using HPLC, an analytical procedure had to be developed and validated. The optimization of the chromatographic conditions was undertaken using a QbD approach. Method: A novel analytical technique effectively separated ferrous fumarate from its degradation products. By exposing the drug to various stresses, such as hydrolysis, oxidation, neutral and photolysis, several by-products are produced. The separation of these degradation products was accomplished in an optimized mobile phase. Results: Ferrous fumarate's retention time was found to be 2.61 mins. The International Council for Harmonisation (ICH) issued recommendations and the method validation was carried out in accordance with them. Conclusion: The established approach can be used as a guide by pharmaceutical companies to undertake routine analyses of the drug in pharmaceutical dosage forms.