Analytical quality by design approach for estimating rosuvastatin calcium in pharmaceutical formulation by green HPLC method: Ecologically evaluated and stability-indicating

Abstract

The pharmaceutical industries rely heavily on liquid chromatographic methods for routine quality control, which utilize hazardous solvents and have a direct impact on the environment. Hence, the development of green liquid chromatographic methodologies has become vital with its green assessment and its application in quality control laboratories has become the need of the hour. The prime focus of the existing study was to develop analytical quality by design aided stability indicating green high performance liquid chromatography (HPLC) method for the estimation of rosuvastatin calcium (RC) in a tablet dosage form. The critical chromatographic factors were the % of ethanol in the mobile phase, and flow rate, their overall effect on the responses like capacity factor, tailing factor and theoretical plates were studied to optimize the method. A rotatable central composite design was employed, and the optimized conditions for chromatographic separation were made with a run time of 12 minutes using Zorbax C18 column (4.6 × 150 mm, 5 μm) with 0.5% v/v acetic acid and ethanol (52.7:47.3 v/v) as components of a mobile phase, flowing at a rate of 0.978 ml/minute. Photodiode array detection was carried out at 246 nm. According to the The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, the proposed method was validated and stress studies revealed that RC is prone to acidic and photolytic stress conditions. An analytical eco-scale score evaluated the greenness profile, and a software-based evaluation Analytical Greenness metrics, which affirmed excellent greenness. The developed HPLC method is more eco-friendly and shall be adopted in the routine quality control of RC in a tablet dosage form.