Development and validation of a stability-indicating RP-HPLC method for the estimation of Fluvastatin sodium in bulk and tablet dosage form
1 New Jersey Bioscience Centre, 675 US Highway 1, North Brunswick, New Jersey, USA.
2 Harrisburg University of Science and Technology, Pennsylvania, USA.
Research Article
Open Access Research Journal of Life Sciences, 2021, 02(01), 015–022.
Article DOI: 10.53022/oarjls.2021.2.1.0122
Publication history:
Received on 20 August 2021; revised on 07 October 2021; accepted on 09 October 2021
Abstract:
A simple and gradient RP- HPLC method has been validated and developed for Fluvastatin Sodium in bulk and tablet dosage form. The proposed method was validated to obtain official requirements including stability, accuracy, precision, linearity and selectivity. The method was developed on Hypersil ODS C18 column (150 x 4.6 mm, 5micron) using the mobile phase consists of methanol: 20mM Phosphate buffer (pH 3.2 adjusted with Phosphoric acid): acetonitrile (55: 30: 15 v/v) was delivered at a flow rate of. The flow rate was set as 1.1 ml/minute and the maximum absorption were observed at 234 nm. The Fluvastatin Sodium drug showed a precise and good linearity at the concentration ranges of 3-15 µg/ml. The RP-HPLC, assay showed the highest purity ranging 99.88 % to 100.09 % for Fluvastatin Sodium tablet formulation and 100.02 % was the mean percentage purity. The Fluvastatin Sodium retention time was found to be 5.5 minutes. The method accuracy was showed by statistical analysis. The developed RP-HPLC method can be adopted for the routine analysis of Fluvastatin Sodium in bulk and pharmaceutical dosage forms in quality control laboratories. The developed method was validated according to the ICH guidelines.
Keywords:
Fluvastatin Sodium; Methanol; Buffer; Acetonitrile; HPLC
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