Development and validation of a fast, simple and specific stability indicating RP-HPLC method for determination of Dexpanthenol in eye gel formulation.

Document Type: Research article

Authors

1 Food Safety Research Center, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

2 Department of Pharmaceutics, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.

3 Department of Pharmaceutics, Faculty of Pharmacy and Pharmaceutical Sciences, Tehran Medical Sciences, Islamic Azad University, Tehran 193956466, Iran.

4 Department of Pharmaceutics, Pharmaceutical Sciences Branch, Islamic Azad University (IAUPS), Tehran, Iran.

5 Department of Pharmaceutics, Faculty of Pharmacy, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.

Abstract

AIn this study a simple and reliable stability-indicating RP-HPLC method was developed and validated for analysis of Dexpanthenol in an artificial tear formulation. The chromatographic separation was performed on a HPLC C18 column (25.0 cm  4.6 mm, 5 m) using a mixture of 0.037 M monobasic potassium phosphate in water (adjusted with 0.1% (v/v) phosphoric acid to a pH of 3.2) and methanol (90:10). The flow rate was set at 1.5 ml/min and Dexpanthenol concentration was determined at λmax = 205 nm. The HPLC analysis method was validated in the terms of linearity, precision, accuracy, specificity, sensitivity according to International Conference on Harmonization (ICH) guidelines. The results showed that the retention time was 8 min and no interferences were observed from the formulation excipients and stress degradation products. Linear regression analysis of data for the calibration plot showed a linear relationship between peak area and concentration over the range of 10 - 100 μg/ml; the regression coefficient was 0.996 and the linear regression equation was y = 20.011 x + 146.83. This HPLC method was precise and accurate in the range of 10 – 100 μg/ml. Also the dexpanthenol concentration in artificial tear formulation was determined by this HPLC method, which was in accordance with the label claimed. This validated HPLC method could be used for routine analysis, quality control and the stability of analysis of eye gel containing dexpanthenol formulations.

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