Analytical quality by design (AQbD) assisted RP-HPLC technique for quantification of Picroside II in bulk and pharmaceutical dosage form

Abstract

Background

Quality by design (QbD) adverts toward gaining of few expected quality with predetermined and desired specifications. Analytical quality by design (AQbD) approach toward the development of analytical method can significantly lead toward the rugged and robust method specially the assessment and risk management compared to traditional approaches. The aim of present study is to develop an analytical method for the estimation of Picroside II in bulk and pharmaceutical dosage form through RP-HPLC assisted by AQbD.

Result

The important critical parameters were methodically optimized by the experimental design space of Box–Behnken, and model graphs were plotted by utilizing Design Expert Software trial version 13.0. The Picroside II separation was successfully done on the HPLC system of Waters equipped through UV-Visible detector on Waters X Bridge RP C18 column having dimensions (4.6 mm × 150 mm, 5.0 μm), mobile phase containing 0.1% formic acid and acetonitrile (77:23%v/v), and rate of flow at 1.0 mL/min. The wavelength for detection was 266 nm; retention time of Picroside II was between 6.0 and 6.2 min with a total duration run time of 10 min. The proposed developed technique was found to be specific, precise (% RSD < 2%), linear (6–14 μg/mL), and robust (% RSD < 1%). Additionally, forced degradation studies were established and the % drug assay was found to be 99.46 ± 0.86% including the results of specificity in terms of peak purity suggesting no interference of any unidentified peak with the chromatographic peak of Picroside II. The results of all the method validation parameters were within the recommended limit of ICH Q2(R1) guidelines. The proposed method was proved to be green as performed by green assessment tools.

Conclusion

The AQbD-based developed method helped in the design and operating space generating with the knowledge of all the method validation characteristics, and the developed RP-HPLC method on the AQbD-based approach was very useful for Picroside II estimation in bulk and pharmaceutical dosage forms.