Specific Stability Indicating RP-HPLC Photodiode Array Based Method for Estimation of Novel combination Atorvastatin Calcium and Vitamin D3 for the treatment of Hyperlipidaemia

Abstract

A specific, precise, accurate, robust and cost-effective stability indicating RP-HPLC method was developed and validated for quantitative analysis of atorvastatin calcium and vitamin D3 in tablet dosage form in the presence of its degradants produced under various stress conditions. These drugs were separated by enable C8 column (15 cm x 4.6 mm, 5 μm), utilizing a mobile phase (93 volume of Methanol: Acetonitrile (50:50) containing 1 mL of 0.1 % formic acid was mixed with 7 mL of 20 mM ammonium formate buffer. The pH of the above mixture was adjusted to 4 using 0.1 % formic acid at a flow rate of 0.6 mL/min, injection volume 5 μL with UV detection at 265 nm. Atorvastatin calcium and vitamin D3 were eluted with the retention time of 3.493 and 9.602 min respectively. The calibration plots were over the concentration range of 50-500 μg/mL and 5-50 IU for atorvastatin calcium and vitamin D3 with correlation coefficient 0.9999 and 0.9996 respectively. Accuracy was obtained between 99.735-100.449 % and 99.768-100.516 % for atorvastatin calcium and vitamin D3 respectively. LOD was found to be 0.2633 and 0.0018 μg/mL and LOQ were found to be 0.7978 and 0.0055 μg/mL for atorvastatin calcium and vitamin D3 respectively. The results showed that the developed method is suitable for the analysis of atorvastatin calcium and vitamin D3 in a tablet dosage form in the presence of generated degradants.