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Information Journal Paper

Title

Development and Validation of A Fast, Simple And Specific Stability Indicating RP-HPLC Method for Determination of Dexpanthenol in Eye Gel Formulation

Pages

  670-676

Abstract

 In 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 mm) 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 λ max = 205 nm. The HPLC analysis method was validated in terms of linearity, precision, accuracy, specificity, and sensitivity according to International Conference on Harmonization (ICH) guidelines. The results indicated 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 μ g/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 μ g/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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  • Cite

    APA: Copy

    MAHBOUBI, ARASH, Gholamreza Alviri, Marjan, & Farhangi, Mahdieh. (2019). Development and Validation of A Fast, Simple And Specific Stability Indicating RP-HPLC Method for Determination of Dexpanthenol in Eye Gel Formulation. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), 18(2), 670-676. SID. https://sid.ir/paper/289102/en

    Vancouver: Copy

    MAHBOUBI ARASH, Gholamreza Alviri Marjan, Farhangi Mahdieh. Development and Validation of A Fast, Simple And Specific Stability Indicating RP-HPLC Method for Determination of Dexpanthenol in Eye Gel Formulation. IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR)[Internet]. 2019;18(2):670-676. Available from: https://sid.ir/paper/289102/en

    IEEE: Copy

    ARASH MAHBOUBI, Marjan Gholamreza Alviri, and Mahdieh Farhangi, “Development and Validation of A Fast, Simple And Specific Stability Indicating RP-HPLC Method for Determination of Dexpanthenol in Eye Gel Formulation,” IRANIAN JOURNAL OF PHARMACEUTICAL RESEARCH (IJPR), vol. 18, no. 2, pp. 670–676, 2019, [Online]. Available: https://sid.ir/paper/289102/en

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