Sustainable and white HPLC method for simultaneous determination of amlodipine and atorvastatin in film-coated tablet

Abstract

This study presents a collaboration between academia and the pharmaceutical industry with one goal, to implement the transformation of the conventional into sustainable HPLC methods and to use these methods in the routine quality control of medicines. Therefore, a sustainable, fast, and robust high-performance liquid chromatography (HPLC) method for the determination of amlodipine (AML) and atorvastatin (ATV) in film-coated tablets was developed. The chromatographic separation was performed on stable bond C8 column (150 × 4.6 mm, 5 μm), using a mixture of ethanol and 0.02 M sodium dihydrogen phosphate monohydrate, pH 3.0 (63:37%, v/v) as a mobile phase. The optimized conditions enabled the determination of AML and ATV within 5 min, providing satisfactory results for system suitability parameters. The method was validated in accordance with the ICH guideline in terms of specificity, linearity, accuracy, and precision (repeatability and intermediate precision). The robustness of the method was confirmed using the Plackett-Burman experimental design. The greenness features of the method were assessed using the Eco-scale index, the AMGS calculator, and the AGREE tool. The high value of the whiteness score (93.5) confirmed that the method meets the requirements for the three main pillars (analytical, ecological, and economical) for the sustainable method development. The method was applied for the determination of both analytes in pharmaceutical dosage form (film-coated tablets that contains 10 mg AML and 10 mg ATV).