Development and Validation of RP-HPLC Method for the Estimation of Clomiphene Citrate in Pharmaceutical Dosage Form

Author:

Sayare Atul S.1,Undre Priti B.1,Ghode Prashant D.1,Singh Sujata V.1,Ghode Shweta P.2

Affiliation:

1. Department of Pharmaceutical Quality Assurance, JSPM’s Rajarshi Shahu College of Pharmacy and Research, Pune, Maharashtra, India – 411033.

2. Rasiklal M. Dhariwal Institute of Pharmaceutical Education and Research, Pune, Maharashtra, India – 411019.

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.

Publisher

A and V Publications

Subject

Pharmacology (medical),Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

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