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ISSN 2063-5346
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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF EBERCONAZOLE NITRATE BY HPLC.

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Purva Jadhav , Amit J Kasabe , Pravin Kamble
» doi: 10.48047/ecb/2023.12.si8.293

Abstract

A simple, precise and economical HPLC method was developed and validated for the determination of Eberconazole nitrate in Active pharmaceutical ingredients. The method involves the use of easily available inexpensive laboratory reagents. The separation was achieved on the Hi Q SilC18 column, (250 x 4.6 mm, 5µm) column with the isocratic flow. The mobile phase at a flow rate of 1 ml/min, consisted of Methanol: 10mM Sodium dihydrogen Phosphate buffer (90:10 v/v), pH adjusted to 5.0 with orthophosphoric acid. The UV detection was carried out at 261 nm. A linear response was observed over the concentration range of 5- 30 µg/ml of Eberconazole nitrate. The method was successfully validated in accordance with ICH guidelines acceptance criteria for specificity, linearity, accuracy, precision, ruggedness and system suitability. The degree of reproducibility of the results obtained as a result of small deliberate variations in the method parameters and by changing analytical operators has proven that the method is robust and rugged.

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