Published Paper Details:

A new, simple and precise RP-HPLC method was developed in this study for the quantitative analysis of lenalidomide (LLM) in pharmaceutical formulations using an analytical quality by design approach. Inertsil C8 mobile phase analytical columns containing a phosphate buffer were used for this purpose in the estimation of LLM and its degradation products present in the mixture of buffer, acetonitrile and methanol in the ratio 80:8:12 (v v/v). The 1.0 ml / minute flow rate is maintained and all degradation tests are conducted using the UV/VIS detector at 254 nm. Method Validation is carried out in compliance with the guidelines and criteria of the International Council for Harmonization (ICH); precision, accuracy, specificity, stability, robustness, linearity, quantization limit 0.25 ?gml-1 (LOQ) and detection limit 0.75?gml-1 (LOD) were successfully evaluated. The current RP-HPLC method indicates that the peaks' purity angle is less than their threshold angle, suggesting that it is ideal for stability studies. For the effective separation of LLM and its impurities in the pharmaceutical dosage formulations, the established method may therefore be used.