Validated Ultra HPLC Method for the Simultaneous Determination of Atorvastatin, Aspirin, and their Degradation Products in Capsules

Abstract

An Ultra HPLC method was developed and validated for the simultaneous determination of atorvastatin, aspirin, and their major degradation products in capsules. Salicylic acid, acetylsalicylsalicylic acid, salicylsalicylic acid, and the lactone form of atorvastatin were separated along with six unknown degradation products within 4 min. The chromatographic separation was performed on acquity UPLCTM BEH C18 column (1.7 µm, 2.1 × 50 mm); using a gradient elution of acetonitrile and phosphate buffer (0.01 M, pH 2.0) at a flow rate of 0.6 mL/min. UV detection was performed at 247 nm. The method was validated for accuracy, repeatability, reproducibility, and robustness. Stability indicating capability was established by forced degradation experiments and separation of known degradation products. Linearity, LOD, and LOQ was established for atorvastatin, aspirin, and their known degradation products.