DEVELOPMENT COLORIMETRY METHODS FOR DETERMINATION OF LISINOPRIL AND HYDROCHLOROTHIAZIDE

• Main Author: Rahmawati Rizkuloh, Lina
• Format: Theses
• Language: Indonesia
• Online Access: https://digilib.itb.ac.id/gdl/view/44512
• Institution: Institut Teknologi Bandung

Simple, sensitive and economical colorimetric methods for the determination of Lisinopril and Hydrochlorothiazide from multicomponents tablet have been developed. The methods for Lisinopril were based on the reaction of the drug with ascorbic acid in DMF medium resulting in the formation of a coloured product, which absorbed maximally at 525 nm. And Hydrochlorothiazide were determined colorimetrically based on Bratton-Marshall reaction after diazotization and coupling with N-(1-Naphthyl)-1,2-Ethanediamine, which absorbed maximally at 518 nm.The calibration curve is linear over the range of 10-60.0 ?g/mL and is described by the regression equation y = 0,00953x with a regression coefficient (r) of 0,998123 for Lisinopril and y = 0,01599x with a regression coefficient (r) of 0,999479 for Hydrochlorothiazide. The limits of detection (LOD) and quantification (LOQ) calculated from calibration curves as per ICH guidelines are 3,68 ?g/mL and 12,26 ?g/mL for Lisinopril; and for Hydrochlorothiazide are 2,03 ?g/mL and 6,78 ?g/mL, respectively. The within-day accuracy expressed as relative error with precision (RSD) ranging from 0,86%; 0,66% and 1,44% for Lisinopril; and 0,34%; 0,36%; 0,52% for Hydrochlorothiazide, respectively. The between-day accuracy RSD are 0,4% for Lisinopril and 0,13% for Hydrochlorothiazide. Accuracy was also checked by placebo blank and synthetic mixture analyses besides a recovery study via spiked-placebo procedure and % recovery are 98,45 – 101,97% for Lisinopril dan 99,07 – 101,87% for Hydrochlorothiazide. Robustness test showed that there was no difference in the results of the analysis after little change in the heating time and the small variations in the amount of the derivatives agents. It showed RSD and the difference between the value of the parameter changes from normal conditions are less than 2%. The method was successfully applied to the analysis of multicomponent tablets containing Lisinopril and Hydrochlorothiazide, resulting % recovery 99,65 – 100,02% for Lisinopril and for Hydrochlorothiazide 99,54 – 100,23%. The proposed methods have been successfully applied to the determination of Lisinopril and Hydrochlorothiazide in commercial multicomponent tablets.