ABSTRACT

A simple, accurate and precise Stability indicating RP-HPLC method was developed and validated for estimation of Sucroferric oxyhydroxide in presence of its degradation products in API. A simple and easy UV spectrophotometric method used for developing the simple calibration curve of drug. The method based on the measurement of absorbance at 254 nm using distilled water as a solvent. The RP-HPLC method has shown adequate separation for Sucroferric oxyhydroxide from its degradation product using the kromosil C18, 150 ?m X 4.6 mm, 5?m column with a mobile phase consisting of methanol: water in the ratio of (10:90 v/v) at flow rate of 1ml/min, using 25°C column oven temperature with UV detection at 254nm. The retention time for Sucroferric oxyhydroxide was 2 ± 0.4 min. The linearity was found to be in the concentration range of 20-100 ?g/ml and correlation coefficient was 0.999. The limit of detection was 2.598 ?g/ml and limit of quantification was 7.873 ?g/ml. The % recoveries at 80%, 100% and 120% were found to be within the limit of 98-102%. Sucroferric oxyhydroxide were exposed to acidic, basic, oxidative, thermal and photolytic stress conditions for forced degradation studies according to ICH guideline. The forced degradation behaviour showed that Sucroferric oxyhydroxide was more prone to degradation. In specific acidic and thermal conditions shows more prone to degradation than the other stress conditions. Degradation was found to be lesser extent in oxidative degradation. Developed stability indicating method was validated as per ICH guideline for linearity, specificity, accuracy, precision and robustness for estimation of Sucroferric oxyhydroxide was found to be satisfactory. Keywords: Sucroferric oxyhydroxide, Chronic Kidney Disease, High Performance Liquid Chromatography, Validation, Force degradation study
Publication date: 01/12/2023

https://ijbpas.com/pdf/2023/December/MS_IJBPAS_2023_7391.pdf

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https://doi.org/10.31032/IJBPAS/2023/12.12.7391