DEVELOPMENT AND VALIDATION OF FIRST-ORDER DERIVATIVE UV-SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF FLUVASTATIN SODIUM IN FORMULATIONAbstract
A simple, accurate, precise and sensitive first-order UV – Spectrophotometric assay method has been developed and validated for the quantitative estimation of fluvastatin sodium in pharmaceutical dosage forms. The solvent to dissolve the drug and for dilutions, methanol was used. The absorption maxima of fluvastatin sodium in methanol after derivatized into the first-order derivative was found to be 306nm. The drug obeyed Beer’s law in the concentration range of 1 – 5µg/mL with correlation coefficient of 0.9997. The developed method was validated as per the ICH guidelines. The % recovery values were found to be within limits, which showed that the method was accurate. The % relative standard deviation values were less than 2, indicating the method was found to be precise. Limit of detection and limit of quantitation were calculated using statistical methods. The developed method can be used for the quality control of fluvastatin sodium in pharmaceutical dosage formulations.
Jahnavi Bandla *, Nameera Jabeen and Ashok Gorja
Department of Pharmaceutical Analysis and QA, Faculty of Pharmacy, Vishnu Institute of Pharmaceutical Education and Research, Narsapur, Medak, Telangana, India.
04 February 2021
02 May 2021
29 May 2021
01 December 2021