Different Approaches in Determination of Lercanidipine in Presence of its Degradation Products by Stability Indicating Univariate and Multivariate Calibrations

Abstract

For quantitative determination of Lercanidipine (LERC) in presence of its acidic and basic degradation products, three spectrophotometric methods were developed. The methods were applied on both the bulk powder and the pharmaceutical formulation. They are precise, accurate, selective, and stability indicating methods. The first method is the new extended derivative ratio method for determination of the drug in presence of the basic (BAS) and acidic (ACD) degradation products. The second and third methods are chemometric methods namely Principal Component Regression (PCR) and Partial Least Squares (PLSs). Full validation of the methods was done according to the ICH guidelines. The calibration curve for the drug was found linear in the range of 5-50 μg / mL for with accepted mean correlation coefficient. A reported HPLC method was compared with the methods and no significant differences were found.

Key words:

• Lercanidipine
• Stability indicating
• Extended Derivative Ratio
• PCR
• PLSs