Chromatographic Method Development and Validation Assay of Apremilast in Tablet Dosage Form

Abstract

The present work involves the development of simple, accurate, precise
and stable RP- HPLC method for the estimation of Apremilast in the
tablet dosage form. The method has several advantages, including simple
and mobile phase, low cost solvents, rapid analysis, and simple sample
preparation. In developed method, the analyte was resolved by using
isocratic method and mobile phase was used Methanol: Water (80:20
v/v), at a flow rate 0.8 ml/min, the detection was carried out at 231nm.
The results of analysis in the method were validated in terms of
accuracy, precision, linearity, robustness. Linearity for Apremilast was
found in the linear concentration range of 10-50 μg/ml with regression
coefficient r2
= 0.9998. The % RSD values for intra-day and inter-day
precision studies were found to be less than 2%. The % recovery was
found to be within an acceptable limit 98%-102%. Therefore the
developed method said to be linear, precise, accurate, and robust. Since
the method does not require use of expensive reagent and also less time
consuming, it can be performed routinely in industry for a routine
analysis of marketed product of Apremilast in tablet dosage form.