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Validated RP-HPLC method for the determination of estradiol valerate in bulk and pharmaceutical formulations | Abstract
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Abstract

Validated RP-HPLC method for the determination of estradiol valerate in bulk and pharmaceutical formulations

Author(s): M. Madhu, Satyadev T. N. V. S. S., G. Hephzibah and T. V. Reddy

The main objective of the present work is to develop a specific validated HPLC method for the determination of Estradiol valerate in bulk and pharmaceutical dosage forms. A reverse phase HPLC method was developed using μ Bondapak Phenyl 5μm (3.9 mm x 30 mm) column and mobile phase of composition Acetonitrile : Water in the ratio of 80:20 v/v at a flow rate of 0.8 mL/min with UV detection at 220 nm for Estradiol Valerate. The retention time of the drug was 2.262 minutes. The developed method was validated for specificity, linearity, precision, accuracy and robustness as per ICH guidelines. Linearity was found in the range of 0.04-0.12mg/ml. The mean recovery of the drug was 80.0 %. The proposed method could be used for routine analysis of Estradiol valerate in their dosage forms. The proposed method is accurate, precise, simple, sensitive and rapid and can be applied successfully for the estimation of estradiol valerate in bulk and in pharmaceutical formulations without interference and with good sensitivity.