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RESEARCH JOURNAL OF PHARMACY AND TECHNOLOGY
Year : 2021, Volume : 14, Issue : 3
First page : ( 1673) Last page : ( 1679)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2021.00297.3

Development and validation of a new stability indicating ultra-fast liquid chromatographic (RP-UFLC) method for the quantification of Rosuvastatin

Naveen Paladugu Venkata*, Ganapaty Seru

Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, Andhra pradesh-530045, India

*Corresponding Author E-mail: paladuguvenkatanaveen@gmail.com

Online published on 30 April, 2021.

Abstract

Rosuvastatin is a HMG-CoA reductase inhibitor used to prevent cardiovascular diseases. Rosuvastatin acts by lowering cholesterol production in the body which blocks the blood flow to heart, brain and other parts of the body. A new validated reverse phase ultrafast liquid chromatographic method has been developed for the estimation of Rosuvastatin in pharmaceutical formulations (Tablets). Mobile phase consisting of a mixture of sodium acetate: acetonitrile (28: 72, v/v) with a flow rate 1.2 mL/min and UV detection at 254 nm was used for the assay of Rosuvastatin. Rosuvastatin was exposed to different stress conditions such as acidic, alkaline, oxidation and thermal degradation. Linearity was observed over the concentration range 0.5–200 μg/mL with linear regression equation y = 32548x-16862 (r2 = 0.9999). The LOQ was found to be 0.04291 μg/mL and the LOD was found to be 0.01502 μg/mL. The present method can be applied for the assay of pharmaceutical formulations, pharmacokinetics study and bio analytical estimations.

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Keywords

Rosuvastatin, Stability indicating, RP-UFLC, Validation, ICH guidelines.

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