Original Articles
Pankaj P Kapupara and Ravi P A
Abstract
A Simple accurate and validated RP-HPLC method for Determination of Potential Synthetic Adulteration of PDE-5 inhibitors in herbal formulation was developed. Chromatographic separation was operated with Methanol: Water (60:40 v/v) at a flow rate of 1 ml/min on Agilent C18 column (4.6 mm I.D. × 100 mm, 5 μm), using 232 nm as detection wavelength. The retention time for Sildenafil Citrate, Tadalafil and Testosterone Propionate was found to be 2.35 min, 1.75 min and 6.25 min respectively. The method was linear over the concentration range of 10-60 μg/ml and coefficient correlation were found to be 0.9973, 0.9947 and 0.9927 respectively. The LOD values for Sildenafil Citrate, Tadalafil and Testosterone Propionate were found to be 0.753, 0.775 and 0.544 μg/ml and LOQ values were 2.282, 2.350 and 1.649 respectively. This method was validated for intraday precision, interday precision, repeatability, robustness and ruggedness. This method can be successfully be applied for determination of synthetic adulterants.