RP-HPLC Method for Simultaneous Estimation of Atorvastatin Calcium and Felodipine from Tablet Dosage Form.

Abstract

The objective of the present study was to develop a simple, accurate, precise and rapid reversed-phase HPLC method for prepared bilayered tablet of Atorvastatin calcium (ATR) and Felodipine (FEL) and subsequent validation using ICH suggested approach for the estimation of both the drugs in combined dosage form. The chromatographic separation of ATR and FEL was achieved on a KYA TECH HiQ Sil C18HS (250 x 4.6 mm, 5 µm) column using a mobile phase of acetonitrile: water [70:30 %V/V]. The flow rate was 1 mlmin-1 with detection at 238 nm. The retention times were 1.86 and 11.46 min for ATR and FEL respectively. The proposed method provided linear responses within the concentration range of 5-30 µgml-1 for both the drugs with LOD values of 0.09 and 0.12µgml-1 for ATR and FEL respectively. Correlation coefficients (r) of the regression equations were greater than 0.999 in all sets. The precision of the method was demonstrated using intra-and inter-day assay R.S.D. values which were less than 2% in all instances. No interference from any components of pharmaceutical dosage forms or degradation products was observed. The percentage recoveries obtained for ATR and FEL ranges from 99.21 to 100.74 %. Method validation results showed that, the proposed method was found to be specific, accurate and precise. It could be applied to the quantitative analysis of these drugs in tablets containing ATR-FEL or ATR-FEL binary mixture.