Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF TEMOZOLOMIDE BY UV-SPECTROSCOPY

Sujan Bathula*, Ramjan Ali, Rousan Roufiuzzaman, L. Shashidhar

ABSTRACT

Pharmaceutical analysis simply means analysis of pharmaceuticals. Webster’ dictionary defines a pharmaceutical is a medical drug. A more appropriate term for a pharmaceutical is active pharmaceutical ingredient (API) or active ingredient to distinguish it from a formulated product or drug product is prepared by formulating a drug substance with inert ingredient (excipient) to prepare a drug product that is suitable for administration to patients. Research and development (R&D) play a very comprehensive role in new drug development and follow up activities to ensure that a new drug product meets the established standards is stable and continue to approved by regulatory authorities, assuring that all batches of drug product are made to the specific standards utilization of approved ingredients and production method becomes the responsibility of pharmaceutical analysts in the quality control (QC) or quality assurance department. The methods are generally developed in an analytical R&D department and transferred to QC or other departments as needed. At times they are transferred to other divisions. By now it should be quite apparent that pharmaceutical analysts play a major role in assuring the identity, safety, efficacy, and quality of drug product, safety and efficacy studies required that drug substance and drug product meet two critical requirements. 1. Established identity and purity. Established bio availability/dissolution

Keywords: quality control (QC), identity and purity, Research and development (R&D), availability/dissolution, active pharmaceutical ingredients.