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Abstract

STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF CLOMIPHENE CITRATE IN PHARMACEUTICAL DOSAGE FORM

Nirav Vaghasiya*, Bipin Paghadar, Tushar Mahajan

Department of Quality Assurance, Noble College of Pharmacy, Junagadh, Gujarat, India.

ABSTRACT

A simple, rapid and accurate and stability indicating RP-HPLC method was developed for the estimation of Clomiphene Citrate in pure and tablet forms. The method showed a linear response for concentrations in the range of 50-150 μg/mL using Acetonitrile: Phosphate Buffer solution (Dissolve 0.05 M potassium di-hydrogen orthophosphate in water.) in the ratio (60:40) as the mobile phase with detection at 245 nm and a flow rate of 1 mL/min and retention time 2.61 min. The value of correlation coefficient, slope and intercept were, 0.998, 1433 and 12098, respectively. The method was validated for precision, recovery, ruggedness and robustness. The drug undergoes degradation under acidic, basic, oxidative, Thermal and Photolytic degradation conditions. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from its degradation product, it can be employed as a stability-indicating one.

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