A Novel Eco-Compatible Green UV-Spectroscopic Analytical Method Development and Validation for Apremilast Estimation in Bulk, Marketed Formulation and in Nanovesicles

Background

The proposed study focuses on developing and validating a sensitive and simple UV-spectroscopic technique for apremilast quantification in bulk drug, commercial tablet, cubosomes and transferosomes.

Materials and Methods

The optimum conditions for analysing apremilast were developed with methanol and phosphate buffer pH 6.8. It shows maximum absorbance at 230nm wavelength. QC standards were used for determining several validation parameters for analytical methods, including accuracy, precision, LOD, LOQ, robustness and ruggedness. In accordance to ICH Q2 (R1) guidelines, the validated technique was applied to quantify apremilast in commercial tablets, bulk, cubosomes and transferosomes.

Results and Discussion

Apremilast exhibited a maximum absorption at a wavelength of 230 nm. Calibration curve was plotted at concentration ranging from 0.2-1.0 µg/mL, with linear equation of y = 0.8017x + 0.0105 and coefficient of variance was observed to be 0.998. The detection limits and quantification limits were found to be 0.09 µg/mL and 0.28 µg/mL respectively. Repeatability and precision results were within (2%) acceptable ranges. Apremilast recovery in marketed formulations, cubosomes and in transferosomes was found to be between 100.47%, 99.97% and 98.35 respectively.

Conclusion

The proposed analytical technique was observed to be novel, eco-friendly, reliable and precise for quantifying apremilast in bulk, commercial tablets, cubosomes and transferosomes. It can be used in the pharmaceutical industry for apremilast in various formulations.