Development and Validation of the RP-HPLC Method for Cis- Bromo Benzoate Determination in Itraconazole API and its Pharmaceutical Dosage forms
| International Journal of Applied Chemistry |
| © 2017 by SSRG - IJAC Journal |
| Volume 4 Issue 3 |
| Year of Publication : 2017 |
| Authors : Durga babu Mannem, Surendra babuKesana |
10.14445/23939133/IJAC-V4I6P101
How to Cite?
Durga babu Mannem, Surendra babuKesana, "Development and Validation of the RP-HPLC Method for Cis- Bromo Benzoate Determination in Itraconazole API and its Pharmaceutical Dosage forms," SSRG International Journal of Applied Chemistry, vol. 4, no. 3, pp. 34-40, 2017. Crossref, https://doi.org/10.14445/23939133/IJAC-V4I6P101
Abstract:
An Isocratic RP-HPLC method was developed for the quantitative determination of Cis-Bromobenzoate (CBB) in Itraconazole API and its pharmaceutical formulations.The baseline separation for Itraconazole and Cis-Bromobenzoate was achieved by utilizing a Symmetry C18 (100 mm × 4.6 mm) 3.5 μm column particle size and an Isocratic elution method. The mobile phase contains a mixture of 0.1% formic acid in Water and Acetonitrile in the ratio of 35:65 v/v, respectively. The flow rate of the mobile phase was 1.0 ml/min with a column temperature of 25°C and detection wavelength at 227 nm.Themethod was validated for limit of detection, limit of quantification, linearity, accuracy and reproducibility with the help of the exhibit and simulated samples. The limit of detection for CBB was 0.30 μg/mL respectively. The limit of quantification (LOQ) for CBB was 0.92 μg/mL respectively. The correlation coefficient obtained for impurity was > 0.999. The recovery was obtained for impurity was 100±10%. The developed method was validated as per ICH guidelines with respect to specificity, precision, linearity, Accuracy, limit of detection and quantification, Ruggedness, robustness and Solution stability.
Keywords:
Itraconazole, Cis-Bromobenzoate (CBB), RP- HPLC, Method development and validation.
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