Stabilty-indicating Method Development and Validation for Determination of Ranoloazine in Raw Material Using Reversed-phase Liquid Chromatography PDF Download

Author: Mohammed T. Shatat
Publisher:
ISBN:
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Languages : en
Pages : 174

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Book Description
"Ranolazine is in a class of anti-anginal medication. It is a new, cardio-selective and metabolism regulating anti-anginal drug. By preventing overload of the calcium ions, Ranolazine diffusely inhibits entry to the sodium current which in turn restores flow of oxygen and blood without change of heart rate or blood pressure. Ranolazine is administered to treat myocardial infarction, congestive heart disease, angina, and arrhythmia. The main focus of this endeavor was to develop a fast, simple, and reliable stability indicating reversed-phase high performance liquid chromatography method that would separate Ranolazine from its related substances in raw material. Degradation was observed for Ranolazine in acidic, basic, and oxidative conditions. Successful chromatographic separation of the drug from the degradation products was achieved on a Waters Symmetry Shield C 18, (250 x 4.6 mm 5 μm) column using a mobile phase consisting of a combination of Phosphate buffer pH 7.0 and Acetonitrile in ratio 600:400 at flow rate of 1.0 ml/minute under isocratic elution at ambient temperature. The eluent showed maximum absorption at 225 nm. The proposed method was validated in terms of linearity, specificity, stability, robustness, precision and accuracy. All parameters were met within the acceptance criteria provided within the ICH guidelines."--