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Abstract

A rapid high performance liquid dosage form. A Kinetics C8, 150 mm   or equivalent in isocratic mode, with mobile phase containing a mixture of 0.01 M potassium di-hydrogen phosphate buffer (adjusted to pH 6.8. using 0.2 M sodium hydroxide): buffer:  acetonitrile in the ration of 55:45 v/v. The mobile phase was pumped at a flow rate of 1.0 ml/min and the eluents were monitored at 241 nm. The selected chromatographic conditions were found to effectively separate r Sacubitril and Valsartan 24mg/26mg ( about RT: 5.98 min and about 7.012 ). The method was validated in terms of linearity, accuracy, precision, and specificity, limit of detection and limit of quantitation. Linearity for Sacubitril and Valsartan 24mg/26mg were found okay respectively. The percentage recoveries for Sacubitril and Valsartan 24mg/26mg ranged respectively.. The method was found to be robust and can be successfully used to determine the drug content of marketed formulations. The method gives resolution with a short analysis time (< 11min). The method parameter was validated and establishes to be simple, sensitive, accurate and precise. Percentage of recovery shows that the method is free from interference of the excipients used in the formulation. Therefore, the planned method can be used for routine analysis of Sacubitril and Valsartan 24mg/26mg in medical dosage form.

Keywords

Sacubitril Valsartan RHPLC Dissolution Validation

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