Vol. 5, Issue 1, Part A (2023)

The accurate quantification of pharmaceutical compounds in tablet dosage forms is paramount for ensuring product quality and efficacy. Pitavastatin, a potent HMG-CoA reductase inhibitor prescribed for hypercholesterolemia management, necessitates robust analytical methods to determine its content with precision and reliability. This abstract presents the development and validation of a new stability-indicating high-performance liquid chromatography (HPLC) method for the assay of Pitavastatin in tablet formulations. The HPLC method was meticulously optimized to achieve optimal separation of Pitavastatin from potential degradation products and excipients commonly found in tablet matrices. Chromatographic conditions, including the selection of a suitable stationary phase, mobile phase composition, and detection wavelength, were carefully tailored to ensure accurate and reproducible quantification of Pitavastatin. Validation studies were conducted to assess the method's specificity, linearity, accuracy, precision, robustness, and system suitability, in accordance with regulatory guidelines. Additionally, stress testing experiments were performed to evaluate the method's stability-indicating capability under various forced degradation conditions, simulating potential degradation pathways encountered during product storage and handling.