A validated RP-HPLC method for the estimation of Cinnarizine in tablet formulation: evaluation of intrinsic stability, greenness and whiteness matrices

Abstract

Background

The major focus of the research was to optimize and validate an eco-friendly, cost-effective, high-performance and throughput RP-HPLC technique for the quantification of Cinnarizine in marketed formulation and also evaluate intrinsic stability. Further, the proposed analytical method efficiency was compared with three reported methods using green and white algorithmic matrix viz., AES, AGREE, GAPI, RGB and BAGI.

Results

Chromatographic conditions were optimized with Inertsil ODS-3V column (250 × 4.6 mm, 5 μm) with methanol and 0.1% v/v orthophosphoric acid (pH 2.5) in a 95:05 v/v ratio as mobile phase. The analytical wavelength and flow rate were fixed to 254 nm and 0.5 mL min⁻¹, respectively. Inherent stability profile was also carried out as per ICH Q₁A R₂ guidelines. The Cinnarizine was eluted from the column at 3.328 min and the method was validated in accordance with ICH Q₂ R₁. The optimum linearity of the analytical method was fitting over the range of 2–14 µg mL⁻¹ with a correlation constant of 0.9992. The limits of detection and quantification were 0.00621 µg mL⁻¹ and 0.0207 µg mL⁻¹, respectively. The Cinnarizine was found to be stable in acidic, thermal and photolytic conditions. Whereas, maximum degradation has taken place in basic and oxidative degradation. The Greenness and whiteness of the optimized chromatographic conditions were better than those reported methods.

Conclusion

Overall, the optimized RP-HPLC method can be utilized for the quantification of Cinnarizine in the tablet formulation and to generate the stability profile.