ISSN : 0975-9492


Open Access

This website is certified by Health On the Net Foundation. Click to verify.

This site complies with the HONcode standard for trustworthy health information:
verify here.


Title : Simultaneous Method Development and Validation of Atorvastatin and Fenofibrate by RP-HPLC Method in Pharmaceutical Formulation
Authors : Abrar, Patnala Ramya, Akula Srinivas, P. Reena Sowmya, Tayyaba Mahtab
Keywords : Atorvastatin, Fenofibrate, ICH guidelines, Development, Validation
Issue Date : Oct 2018
Abstract :
A simple RP-HPLC method was developed and validated for estimation of Atorvastatin and Fenofibrate in tablet dosage form. Determination of the drugs were carried out on Inertsil ODS (2,250 x 4.6mm; packed with particle size of 5µ) column with a mixture of pH 2.5 phosphate buffer and acetonitrile in the ratio 18:82%v/v as mobile phase at a flow rate of 1.0ml/min at ambient temperature. Detection was monitored at 260 nm. The retention time was 3.5 and 7.06 min for Atorvastatin and Fenofibrate respectively. The validation parameters of the developed method such as specificity, linearity, precision, accuracy, stability and robustness were evaluated as per ICH guidelines. Linearity of the method was achieved over the concentration range of 5.003 – 60.03 µg/ mL for Atorvastatin and 144.225-480.750µg/ mL for Fenofibrate. The LOD and LOQ values were found to be 1.005 and 3.04 µg/ mL for Atorvastatin whereas 5.47 and 16.60 µg/ mL for Fenofibrate respectively. The developed method can be adopted for simultaneous determination of Atorvastatin and Fenofibrate in tablet dosage forms.
Page(s) : 131-137
ISSN : 0975-9492
Source : Vol. 9, No.10