Abstract

EFFECT OF PANTOPRAZOLE ON THE BINDING OF ATORVASTATIN TO BOVINE SERUM ALBUMIN BY VALIDATED HPTLC METHOD – AN IN VITRO METHOD

Sangeetha R. K.*, Yoghalakshmy N. and Geetha M.

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Abstract

The HPTLC method for the simultaneous determination of Atorvastatin and Pantoprazole was developed by using the solvent system composition made up of Toluene: Dichloromethane: Tetrahydrofuran in the ratio of 2:2:6 v/v/v with 0.1 ml glacial acetic acid with a chamber saturation time of 20 minutes travelled till 8 cm on the plate. The band width applied was 6 mm with detection wavelength of 286nm. The method developed was validated for the parameters as per the ICH Q2(R1) guidelines for specificity, linearity, range, accuracy, precision, limit of detection, limit of quantification, robustness and ruggedness. The R value of the drug Atorvastatin was found tobe 0.73±0.04 andforPantoprazole was found to be 0.57 ± 0.03. The peak areas of Atorvastatin and Pantoprazole were found to be linear in the concentration range of 100-600 ng/band and between 50-300 ng/band respectively with >0.99 as the correlation coefficient value. The LOD and LOQ of Atorvastatin was found to be 40 ng/band and 60 ng/band. The detectable limit of Pantoprazole spotted was found to be 10 ng/band whereas the quantifiable limit is 40 ng/band. When both the drugs are present together in the reaction pool the % protein binding was found to be 84.36 and 66.15 for the drug Atorvastatin and Pantoprazole respectively. The increase in the %displacement of the drugs in the mixture when compared with the individual drug binding is an indication to monitor both the drugs whenco administered.

Keywords: Atorvastatin, Pantoprazole, HPTLC Method, Simultaneous Determination, Protein Binding Studies.