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ABSTRACT
| Title |
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Simultaneous Method Development and Validation of Atorvastatin and Fenofibrate by RP-HPLC Method in Pharmaceutical Formulation |
| Authors |
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Abrar, Patnala Ramya, Akula Srinivas, P. Reena Sowmya, Tayyaba Mahtab |
| Keywords |
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Atorvastatin, Fenofibrate, ICH guidelines, Development, Validation |
| Issue Date |
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Oct 2018 |
| Abstract |
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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) |
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131-137 |
| ISSN |
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0975-9492 |
| Source |
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Vol. 9, No.10 |
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