Mon, 18 Dec 2017

RP-HPLC Method development and validation for the Estimation of Etoposide in Bulk Drug and its Pharmaceutical Dosage Form.

B.Lakshmi1*, K.Rama Krishna2, K.N.Jayaveera3, G.V.Padmakar rao4

1. Department of Chemistry, GITAM University, Hyderabad- 502329, INDIA

2. Department of Chemistry, GIS, GITAM University, Visakhapatnam – 530045, AP, INDIA

3. Department of Chemistry, JNTU, Anantapur- 515002, AP, INDIA

4. Aurobindo Research Centre, Hyderabad-500090, India.


ABSTRACT

A specific and accurate HPLC method is developed for the determination of etoposidein bulk drugs and in solid capsule dosage form. Best symmetric peak shape obtained with Inertsil ODS C-18 column (250 X 4.6 mm, 5μ) column in an isocratic mode, with retention time 5 min.The mobile phase used was Water : Acetonitrile  60:40(v/v)with flow rate 1.0 ml/min and effluent was monitored at 263 nm. As per ICH guidelines method has validated. Method has found linear in the range of 5-45 µg/ml. The LOD and LOQ were found to be 0.02 and 0.06 µg/ml respectively. Method was found specific with respective of diluents, excipients and degradants.

Keywords: Etoposide, RP-HPLC, ICH guidelines, Method validation.


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