Vol 4, No 2 (2022)

UV-Spectroscopy-Based Method Development and Validation for Bulk and Tablet Sparfloxacin Dosage Estimation

Authors: Ajay Chouhan, Himanshu Prajapati, Dr. Abhishek upadhyay

Abstract: Pharmaceutical analysis is basically the study of medications. A pharmaceutical, according to Webster's dictionary, is a medicinal medication. A pharmaceutical is more appropriately referred to as an active pharmaceutical ingredient (API) or active ingredient to distinguish it from a formulated product or drug product, which is created by combining a drug substance with an inert ingredient (excipient) to create a drug product suitable for administration to patients. Research and development (R&D) play a critical role in new drug development and follow-up activities to ensure that a new drug product meets the established standards, is stable, and continues to be approved by regulatory authorities, and that all batches of drug product are manufactured to the specific standards. Pharmaceutical analysts in the quality control (QC) or quality assurance department are responsible for the use of permitted substances and production methods. In most cases, the methodologies are created in an analytical R&D department and then transferred to QC or other departments as needed. They are occasionally reassigned to different divisions.

Keywords: Quality control, API, Research and development (R&D), Excipient

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