Analytical Qbd-Driven Development and Validation of Stability-Indicating Rp-Hplc Method for Related Substances in Octreotide Acetate Depot Formulations
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Abstract
This study aimed to develop and validate a precise, selective, and robust reverse phase high performance liquid chromatographic method for the determination of octreotide acetate and its related substances in pharmaceutical dosage forms using an analytical quality by design approach. A systematic experimental design was applied to optimize critical chromatographic variables, ensuring consistent separation and reliable performance. The optimized method achieved clear resolution of octreotide acetate from its process- and degradation-related impurities within a single analytical run. Validation demonstrated excellent linearity over the studied concentration range, high accuracy with recoveries within acceptable limits, and satisfactory precision. Statistical evaluation confirmed the significance and reliability of the optimized method. The developed method proved suitable for accurate quantification of octreotide acetate and multiple related substances in dosage forms. Overall, the analytical quality by design strategy enhanced method understanding, robustness, and regulatory acceptability, making the method efficient and reliable for routine quality control analysis in pharmaceutical laboratories.