Development and validation of analytical method for simultaneous estimation of atorvastatin calcium and vitamin d3 in bulk and solid dosage form

Abstract

The RP-HPLC method has shown adequate separation of Atorvastatin Calcium and Vitamin D3in bulk and its synthetic mixture. The separation was achieved on a Phenomenex C18 (250mm X 4.6 mm i.d., 5 μm particle size) with a gradient system of Acetonitrile: Methanol in the ratio of 75:25 v/v, pH adjusted 3.5 with ortho-phosphoric acid. The mobile phase at a flow rate of 1.2 ml/min, Injection volume 20μl and wavelength of detection used was 249 nm. The retention time for Atorvastatin calcium and Vitamin D3 was obtained as 1.7 min and 12.5 min, respectively. The linearity of the proposed method was investigated in the range of 8-28 μg/ml and 2-7 μg/ml for Atorvastatin calcium and Vitamin D3, respectively. Correlation coefficient was 0.9984 and 0.9955 for Atorvastatin calcium and Vitamin D3, respectively. The developed method was validated as per ICH guideline, for its accuracy, precision, LOD & LOQ and the results were found to be satisfactory, thus the method is specific, rapid and simple with good sensitivity for estimation of Atorvastatin calcium and Vitamin D3. These analytical methods are also applicable in ordinary laboratories. It can also be adopted for quality control tests for these drugs in tablets.