RELANI, INDAH
(2014)
UJI DISOLUSI TERBANDING AMLODIPIN
DARI BERBAGAI SEDIAAN TABLET
YANG BEREDAR DI PASARAN.
Other thesis, ANDALAS UNIVERSITY.
Abstract
ABSTRACT
A research of comparative dissolution testing of various dosage amlodipine
tablets in circulation. Quality evaluation was conducted on the physical tablet weight
uniformity, uniformity of size, friability, disintegration time, the value corresponding
to the requirements described in the pharmacopoeia Indonesia, and relatively similar
between amlodipine tablets innovators have higher yields than condition (4-8
kg/cm²). Kromatografri amlodipine concentrations were measured by high
performance liquid detector 273 nm using a mobile phase of phosphate buffer pH
3.0: methanol HPLC grade: acetonitrile pro HPLC (50:35:15), PHPLC grade
methanol, flow rate 1 mL / min, and runtime 30 minutes. Assay of the active
substance in the tablets of amlodipine innovator ranges from around
94.5730±2.1957%, tablets of generic A 89.8894±1.8175%, and tablets of generic B
88,6854±3.4395% and showed innovator tablets eligible only to USP (90-110% ).
Factor similarity dissolution of innovator tablet with generic A f2 = 62.7938 qualify
because being in the range of 50-100, while the factor of similarity with the
innovator tablet generic B does not meet the requirements with the results of f2 =
23.1034. Dissolution profiles depicted from the plot between % dissolved versus
time, and linearity obtained by release kinetics according the equation of Higuchi.
The test is based on the F statistic which showed differences significant between the
type of preparation and time with the results of dissolution levels (P <0.05), and base
on fisher test there is nothing difference of proportion between both of them.
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