Abstract

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 × 4.5mm × 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 flow 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.

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