Stability indicating method development and validation for the estimation of Doxorubicin by using RP-HPLC method in a bulk and pharmaceutical dosage form


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3

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1

Abstract :

A simple and selective RP-HPLC method is described for the determination of Doxorubicin dosage forms. Chromatographic separation was achieved on a C18 column using mobile phase consisting of a mixture of HPLC water (pH 5.8): ACN (55:45v/v), with detection of 281 nm. Linearity was observed in the range 75-150 µg/ml for Doxorubicin (R2 =0.994) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form. The developed RP-HPLC and UV spectrophotometric method were successfully applied for the quantitative determination of cited drugs in pharmaceutical dosage form.
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