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Analytical method development and method validation for the estimation of pantoprazole in tablet dosage form by RP-HPLC | Abstract

Der Pharma Chemica
Journal for Medicinal Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences and Computational Chemistry

ISSN: 0975-413X
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Abstract

Analytical method development and method validation for the estimation of pantoprazole in tablet dosage form by RP-HPLC

Author(s): B. Siddartha and I. Sudheer Babu

A simple, sensitive and rapid reverse phase high performance liquid chromatographic method was developed for the estimation of Pantoprazole in pure and in pharmaceutical dosage forms. A BDS Thermohypersil Symmetry C8 column (250 x 4.6mm x 5 μ) was used with a mobile phase containing a mixture of Methanol and Dipotassium hydrogen phosphate buffer adjusted to pH-9 with ortho phosphoric acid in the ratio of 50:50. The flow rate was 1.2ml/min and effluent was monitored at 226nm and eluted at 4.189min. Calibration curve was plotted with a range from 50-150 μg/ml for Pantoprazole. The assay was validated for the parameters like specificity, system suitability, precision, accuracy, robustness and ruggedness parameters. The proposed method can be useful in the routine analysis for the determination on Pantoprazole in pharmaceutical dosage form.


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