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June 24, 2016
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June 1, 2016
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Abstract
ABSTRACT
Determination ofdrug substance is one of the drug quality control to ensure the safetyof drug.
Determination of cimetidine could use UV spectrophotometry and HPLC. The aim ofthis study
were to validate the methode using two instruments, to compare both of the method and to apply
it intablet dosage forms.
Determination of cimetidin using UV spectrophotometry was set on wave length 219 nm.
Determination using HPLC with coloumn C18 and mobile phase mixture of methanol: water-
phosphoric acid (30:70, v/v), flow rateat 1mL/min and UV detector. The method was validated in
terms of accuracy, precision, linearity, selectivity and sensivity. The method of determination of
cimetidine using both instruments were campared by analysis of variant.
Validation method using UV spectrophotometry showed precision of 0.94%, recovery from
97.50 to 100.91%, good linearity, LOD 0.76 µg/mL and LOQ 2.52µg/mL.Validation using HPLC
method resulted value of precision 0.30%, recovery from 98.42 to 101.83%, good linearity, LOD
and LOQ of 0.46 and 0.56 µg/mL. The average concentration of cimetidine in tablets by
spectrophotometry UV was 101.95%, while in HPLC was 99.69%.The methods accomplied to the
requirements according The Indonesian Pharmacopoeia Edition IV. Both methods provided the
same results and did not significantly different.
Keyword : validation method, cimetidine, UV spectrophotometry, HPLC
Determination ofdrug substance is one of the drug quality control to ensure the safetyof drug.
Determination of cimetidine could use UV spectrophotometry and HPLC. The aim ofthis study
were to validate the methode using two instruments, to compare both of the method and to apply
it intablet dosage forms.
Determination of cimetidin using UV spectrophotometry was set on wave length 219 nm.
Determination using HPLC with coloumn C18 and mobile phase mixture of methanol: water-
phosphoric acid (30:70, v/v), flow rateat 1mL/min and UV detector. The method was validated in
terms of accuracy, precision, linearity, selectivity and sensivity. The method of determination of
cimetidine using both instruments were campared by analysis of variant.
Validation method using UV spectrophotometry showed precision of 0.94%, recovery from
97.50 to 100.91%, good linearity, LOD 0.76 µg/mL and LOQ 2.52µg/mL.Validation using HPLC
method resulted value of precision 0.30%, recovery from 98.42 to 101.83%, good linearity, LOD
and LOQ of 0.46 and 0.56 µg/mL. The average concentration of cimetidine in tablets by
spectrophotometry UV was 101.95%, while in HPLC was 99.69%.The methods accomplied to the
requirements according The Indonesian Pharmacopoeia Edition IV. Both methods provided the
same results and did not significantly different.
Keyword : validation method, cimetidine, UV spectrophotometry, HPLC