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Development and Validation of HPLC Method for the Quantification of Atorvastatin in Pharmaceutical Dosage Forms and Biological Fluid

SK Manirul Haque

Abstract


A reverse phase HPLC method was developed for the determination of atorvastatin. The mobile phase involved for the separation was phosphate buffer and acetonitrile with a ratio of 10:1. The HPLC column C18 ODS hypersil column (250 mm×4.6 mm, 5 μm) was used and detected at 215 nm.   The run time of the current method was 5 minutes with excellent specificity; no interferences were observed in the pharmaceutical dosage form. The process was validated according to ICH guidelines. The linearity of the proposed method was within the range of 0.25–3.8 µg/ml. The LOD and LOQ values were found to be 0.21 and 0.64 µg/ml. The % recovery and %RSD were within the range of 98–100 %, and ±2% for accuracy, precision, robustness, ruggedness results. All the values are acceptable as per ICH guidelines. As well, this enhanced technique was applied to calculate the amount of atorvastatin in human urine samples. Therefore, the present method is reliable for quantifying atorvastatin in quality control samples in academic and pharmaceutical industries and can easily be used in research development and hospitals. 


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References


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DOI: http://dx.doi.org/10.13171/mjc02106301581haque

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