Development and Validation of a Stability-Indicating RP-HPLC Assay Method For The Estimation Of Rizatriptan Benzoate In Tablet Dosage Form

Abstract

This research endeavors to develop and validate a robust method for the assay of Rizatriptan Benzoate tablets utilizing RP-HPLC. Conducted at the Laboratory of ARL in Glenmark Research Centre, Navimumbai, the study encompasses comprehensive investigations into method development and validation protocols. The research begins with an introduction to method development and validation, elucidating various chromatography techniques, HPLC instrumentation, and analytical methodologies. A thorough literature survey reveals existing methods for the drug, laying the groundwork for subsequent experimentation. Subsequent chapters delve into the drug profile, including its physical characteristics, structure, solubility, pharmacological action, and ADME properties. The aim and objectives of the study are outlined, followed by a detailed exploration of the experimental procedures conducted during method development. Various approaches to HPLC method development are explored, with a focus on optimizing chromatographic conditions. The validation protocol is meticulously outlined, covering specificity, linearity, precision, accuracy, ruggedness, and robustness parameters. The validated method demonstrates exceptional performance characteristics, paving the way for routine assay applications in the pharmaceutical industry. Results of the assay method development, including optimized chromatographic conditions and standard concentrations, are presented.In conclusion, the validated method emerges as a reliable tool for the routine assay of Rizatriptan Benzoate tablets, offering specificity, precision, linearity, robustness, and sensitivity. This research contributes to the advancement of pharmaceutical quality control processes, ensuring the safety and efficacy of Rizatriptan Benzoate formulations.