Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Volume - 13 | Issue-1
Cyproterone acetate (CA) is an anti-androgenic drug with progestogenic activity. CA binds to the androgen receptor and prevents androgen-induced receptor activation in target tissues, inhibiting the growth of testosterone-sensitive tumor cells. The current method aims to develop an RP-HPLC method for the detection of CA in both its pure and formulated form. A simple and robust method was developed where separation was carried out with a mobile phase of Acetonitrile: Water at the ratio of 80:20 and flow rate of 1.5ml/min. The detection wavelength was 281 nm. The linearity was performed for a concentration range of 5-25 μg/ml and the regression coefficient were found to be 0.9991. All other validation parameters like accuracy, precision, LOD, LOQ, robustness & ruggedness were performed as per ICH guidelines and results were found to be within limits. The % assay was found to be 97.32 – 98.08%. Though many methods require complex mobile phases such as buffers, where pH must also be maintained, the current research work develops the method using a simple, inexpensive, and easily available mobile phase composition using milli-Q water and acetonitrile. Hence, the proposed data concludes that the developed RP-HPLC method can be used for routine quality control of CA in any formulation.