Stability Indicating Analytical Method Development and Validation For Quantitative Analysis of Some Drugs by HPLC

Abstract

1. BIOANALYTICAL METHOD DEVELOPMENT, OPTIMIZATION AND VALIDATION OF PRANLUKAST IN BIO MATRICES OF HUMAN PLASMA BY RP-HPLC METHOD newlineA simple, rapid, accurate and precise High Performance Liquid Chromatographic method was developed and validated to estimate the presence of Pranlukast, a Cysteinyl leukotriene receptor-1 antagonist , in biomatrices of human plasma by RP-HPLC method. The analyte was extracted by Protein precipitation technique which was achieved with good extraction efficiency. The process of separation was done on RP-HPLC chromatography by using Discovery C18 column with dimensions of 150 mm×4.6 mm×5 and#956;m particle size. Mobile phase (OPA:ACN (40:60)-0.1% OPA ) was programmed in the instrument using an Isocratic technique with 1.00 mL/min flow rate at room temperature and UV-detection was fixed at 257 nm by using PDA-detector. Internal standard (IS) was selected as Montelukast which belongs to same category of analyte. The retention times for Pranlukast (analyte) and Montelukast (IS) was found to be 6.09, 8.01 respectively. Linearity for Pranlukast and Metformin was found to be in the range of 0.02 and#956;g/ml-2.0 and#956;g/ml for both drugs respectively. The method was validated as per the US-FDA guidelines and the results were within the acceptance criteria for all the validation parameters including stability studies. The validated method successfully implemented for estimation of Pranlukast in human plasma samples for application in bioequivalence studies.2. NOVEL DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR THE DETERMINATION OF ELTROMBOPAG IN HUMAN PLASMA MATRICES BY USING PDA-DETECTOR newlineA simple, rapid, accurate and precise High Performance Liquid Chromatographic method was developed and validated to estimate the presence of Eltrombopag, a Thrombopoietin receptor agonist , in biomatrices of human plasma by RP-HPLC method by using PDA-detector. The analyte was extracted by Protein precipitation technique which was achieved with good extraction efficiency. The process of separation was done on RP-HPLC chromatography by using Kromasil C18 column with dimensions of (250 × 4.6 mm,5and#956;) particle size column Mobile phase 45:55; KH2PO4:ACN(Buffer pH of 3.0) was programmed in the instrument using an Isocratic technique with 1.00 mL/min flow rate at room temperature and UV-detection was fixed at 230 nm by using PDA-detector. Internal standard (IS) was selected as Heparin. The retention times for Eltrombopag (analyte) and Heparin (IS) was found to be 3.42 and 4.55mins respectively. Linearity for Eltrombopag and Heparin was found to be in the range of 0.02 and#956;g/ml-0.80 and#956;g/ml for both drugs respectively. The method was validated as per the US-FDA guidelines and the results were within the acceptance criteria for all the validation parameters including stability studies. The validated method successfully implemented for estimation of Eltrombopag in human plasma samples for application in bioequivalence studies. newline