Analytical Method Validation of Testosterone Undecanoate Soft Gelatin Capsule by RP-HPLC Method

Abstract

A rapid, sensitive, selective reversed phase HPLC method has been validated for the quantification of testosterone undecanoate from Andriol® soft gelatin capsule. During validation active pharmaceutical ingredient (API) has been separated by C18 (4.6 mm × 250 mm, 5 µm) column, 100% methanol as mobile phase, flow rate of 0.8 ml/min and detection wavelength at 240 nm. The method was validated according to USP and ICH guideline requirements which includes specificity, accuracy, precision, linearity and range and robustness. Linearity of standard spiked sample was observed for each working day and coefficient of determination (r 2 ) has been found >0.99 each day in concentration ranging from 20-60 ppm. Recovery was found from 98.87-100.02% for 20, 40 and 60 ppm of testosterone undecanoate spiked sample. Precision and intermediate precision showed that % RSD of test sample solution were 0.26 and 0.19 respectively and absolute difference between them was 0.52, all of the values were within acceptable limit. The method was also found robust in changing column oven temperature (± 5°C) and flow rate change (± 0.1).