DEVELOPMENT COLORIMETRY METHODS FOR DETERMINATION OF LISINOPRIL AND HYDROCHLOROTHIAZIDE
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 col...
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| Format: | Theses |
| Language: | Indonesia |
| Online Access: | https://digilib.itb.ac.id/gdl/view/44512 |
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| Institution: | Institut Teknologi Bandung |
| Language: | Indonesia |
| Summary: | 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.
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