Pharmacokinetic evaluation of newly developed isradipine sustained release formulation

Abstract

A specific and efficient method using High Performance Liquid Chromatography (HPLC) has been developed to validate the pharmacokinetics of sustained-release formulation containing Isradipine. The objective of the present study is to develop and validate PK of sustained release formulation containing Isradipine. The plasma samples of Isradipine were extracted using the protein precipitation technique (PPT). The detection wavelength of Isradipine, which was 325nm, was determined using UV spectrophotometer. Reversed phase Thermos c18 column was used for separation. 10mM ammonium acetate buffer (pH 4) and acetonitrile at a ratio of 20:80% v/v was used as the mobile phase with the flow rate of 1.0 ml/min. The linearity achieved in this method was in the range of 10-120 ng/ml. HPLC method provides extremely precise results and is an excellent and efficient method compared to others. The development of a sustained release formulation offers advantages such as prolonged blood levels of the drug and improved patient compliance. The formulated sustained release tablets containing Isradipine is capable of exhibiting sustained release properties, stable and feasible for industrial scale production. Thus they are capable of reducing the dose intake, minimize the blood level oscillations, dose related adverse effects, cost and ultimately improve the patient compliance in the hypertension.