QbD Based Analytical Optimization by UV Spectroscopy Assisted HPLC and HPTLC Methods for Quantification of Voclosporin in Pharmaceutical Formulation

Background

The innovative analytical quantification of lupus medication Voclosporin was developed by HPLC, and HPTLC was abetted by the Ultra Violet spectroscopic method using the QbD approach.

Materials and Methods

The Cary 5000 double-beam spectrophotometer was used to measure the UV absorbance. Chromatographic separation was performed in the Agilent C₁₈ column with mobile phase consisting of different concentrations of Acetonitrile and phosphate buffer. Variables of the methods were optimized by response surface methodology via the Box-Behnken design using Digital expert Stat- Ease -360 software. HPTLC determination was carried out using Camag Linomet with densitometric scanner. The methods were verified as per ICH requirements, the stability of the drugs was considered under a forced stress environment, and observed for transitional degradation pattern.

Results

The drug exhibits HPLC and HPTLC chromatographic peaks with retention periods of 6.18 and 5.61 min respectively with a clear and distinct peak for Voclosporin detected at wavelength maximums of 248 nm. The medication showed a percentage recovery ranging from 97% to 100% w/w.

Conclusion

The developed method was found to be consistent and appropriate for repetitive screening of drugs in bulk dosage form as well as pharmaceutical formulation.