Development and validation of rp-hplc method for the estimation of clomiphene citrate in pharmaceutical dosage form

A simple, specific, precise, and accurate RP-HPLC method has been developed and validated for the estimation of Clomiphene citrate in bulk and pharmaceutical dosage form using C18 column Shimadzu (250mm x 4.5mm x 5μm) with a mobile phase consisting of 900mL of HPLC grade methanol and 100mL of HPLC grade acetonitrile. The mobile phase was sonicated for 10 min and filtered through a 0.45μm membrane filter at a fl ow rate of 1.0mL/min. The detection was carried out at 295nm and retention time of Clomiphene citrate was found to be 3.44 min. Linearity was observed in the concentration range of 10–50μg/mL (coefficient of determination R²=0.999) with regression equation y =20321x + 60021. The method was validated as per ICH guidlines.