HPLC stability-indicating method process

In Section 8.2, the aim of analysis is emphasized especially for the API (active pharmaceutical ingredient) and the drug product. The workflows and the rationale at major decision points during synthetic processing steps where HPLC can be applied in process development are elaborated upon. For example, a fast method is needed to monitor reaction conversion of two components. However, a more complex method would be needed for stability-indicating purposes where multiple degradation products, synthetic by-products, and excipient peaks need to be resolved from the active pharmaceutical ingredient. 

An HPLC method for the estimation of potency and determination of degradation products is an integral part of release testing. The analytical method should be stability indicating and capable of separating the active ingredient peak from degradation product, process impurity, and excipient-related peaks (Fig. 1). 

---