Thu, 23 Nov 2017

Quantification of Everolimus in bulk and tablet dosage forms by a HPLC method coupled with a photodiode array detector

Suresh Kumar Raju Vidyadharani1*, Ravoori Sreenivasulu2

1. Analytical development laboratory, Mylan laboratories limited, Hyderabad, India.

2. Department of chemistry, Sri Krishnadevaraya University College, Anantapuram, India .


ABSTRACT

A rapid, sensitive, precise, and accurate HPLC method coupled with a photodiode array detector was developed, optimized, and validated for the estimation of everolimus in bulk and tablet dosage forms. The chromatographic separation was achieved using a kromosil C8 column (200 mm × 4.6 mm i.d., 5 μm particle size) at 30°C temperature. The isocratic mobile phase consisted of 0.1M dipotassium hydrogen phosphate and methanol (60:40, v/v). The mobile phase was delivered at 1.0 ml/min and the analyte was monitored at 277 nm. The method was successfully validated in accordance to International Conference on Harmonization. The retention time of everolimus was found to be 3.496 min, and the calibration curve was linear in the concentration range of 50-150 μg/ml (R2 = 0.9992). The limit of detection and the limit of quantitation were found to be 0.109 μg/ml and 0.364 μg/ml, respectively.  The proposed method is accurate (percent recoveries were in the range of 99.56-100.09%) and precise (percent relative standard deviation - 0.047 %). No chromatographic interferences from the tablet excipients and components of mobile phase were found. The proposed method was found to be suitable for the quantitative determination of everolimus in tablet dosage forms.

Keywords: Everolimus, Afinitor, HPLC, validation, analysis


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