Penerapan Metode Spektrofotometri Ultraviolet Pada Penetapan Amlodipin Besilat dalam Sediaan Tablet
Penerapan Metode Spektrofotometri Ultraviolet
Pada Penetapan Kadar Amlodipin Besilat dalam Sediaan Tablet
Abstrak
Amlodipintermasukantagoniskalsiumgolongandihidropiridin yang berkerja
menghambatmasuknya ion kalsiummelaluimembrankedalamotot polos vaskular
danototjantung. Tujuan penelitian ini adalah untuk mendapatkan metode alternatif
pada penetapan kadar tablet amlodipin yang relatif lebih murah dan mudah dalam
pelaksanaannya, namun memberikan hasil dengan akurasi dan presisi yang baik
dan sekaligus menentukan kadar tablet amlodipin generik dan nama dagang yang
beredar di pasaran.
Metode yang digunakanpadapenelitianiniyaitusecaraspektrofotometri
ultraviolet dalam pelarut metanol pada panjang gelombang 364 nm. Metode ini
memenuhi persyaratan uji validasi dengan persen perolehan kembali 100,51%
danrelatifstandardeviasi (RSD) 3,7975%, batasdeteksi (LOD) 1,5587 µg/ml
danbataskuantitasi (LOQ) 5,1957 µg/ml.
Dari hasilpenelitiandiperolehkadartablet amlodipin generik (Hexpharm)
sebesar 95,63% ± 1,145% dan tablet namadagang Tensivask® (DexaMedika)
sebesar 94,74% ± 2,70%, Normoten® (Soho) sebesar 94,94% ± 1,81%, Lopiten®
(Guardian Pharmatama) sebesar 96,54% ± 0,90%.
Hasilpenelitianmenunjukkankadaramlodipindalamsediaan
tablet
generikdannama
dagangmemenuhipersyaratan
tablet
padaumumnyayaitutidakkurang dari 90,0% dantidaklebih dari 110,0% darijumlah
yang terterapadaetiket.
Kata kunci : Amlodipin, penetapan kadar, spektrofotometri ultraviolet, validasi
metode
6
Universitas Sumatera Utara
Application of Ultraviolet Spectrophotometry Method on Determination of
Amlodipine Besilat in Tablet Preparations
Abstract
Amolodipine is one of antagonis calcium the group of dihidropiridin
which inhibit the entry of calcium ions through the membrane into the vascular
smooth muscle and cardiac muscle. The purpose of this study to find an
alternative method to determination of amlodipine tablets which are relatively
cheap and easy in implementation, but it gives results with good accuracy and
precision and olso to determine the levels of amlodipine tablet generic and trade
names on the market.
The name as the method which is used to the study is ultraviolet of
spectrophotometry with solvent of methanol at a wavelength of 364 nm. This
method meets the requirements validation test with the recovery percent is
100,51% and deviation standard of relative (RSD) is 3,7975%, detection of limit
(LOD) is, 1.5587 g/ml and quantitation of limit (LOQ) is, 5.1957 g/ml.
From the study were obtained the generic rate of amlodipine tablets
(Hespharm) equal to 95.63% ± 1.145% and the trade names Tensivask® tablets
(Dexa Medika) equal to 94.74% ± 2.70%, Normoten® (Soho) equal to 94.94% ±
1.81%, Lopiten® (Guardian Pharmatama) amounted to 96.54% ± 0.90%.
The study showed that levels of amlodipine in tablet dosage generic and
trade name meets the requirements of tablets in the general are not less than
90.0% and not more than 110.0% of the listed amount on the label.
Key words:amlodipine, determination, spectrophotometry ulraviolet, validation
methods.
7
Universitas Sumatera Utara
Pada Penetapan Kadar Amlodipin Besilat dalam Sediaan Tablet
Abstrak
Amlodipintermasukantagoniskalsiumgolongandihidropiridin yang berkerja
menghambatmasuknya ion kalsiummelaluimembrankedalamotot polos vaskular
danototjantung. Tujuan penelitian ini adalah untuk mendapatkan metode alternatif
pada penetapan kadar tablet amlodipin yang relatif lebih murah dan mudah dalam
pelaksanaannya, namun memberikan hasil dengan akurasi dan presisi yang baik
dan sekaligus menentukan kadar tablet amlodipin generik dan nama dagang yang
beredar di pasaran.
Metode yang digunakanpadapenelitianiniyaitusecaraspektrofotometri
ultraviolet dalam pelarut metanol pada panjang gelombang 364 nm. Metode ini
memenuhi persyaratan uji validasi dengan persen perolehan kembali 100,51%
danrelatifstandardeviasi (RSD) 3,7975%, batasdeteksi (LOD) 1,5587 µg/ml
danbataskuantitasi (LOQ) 5,1957 µg/ml.
Dari hasilpenelitiandiperolehkadartablet amlodipin generik (Hexpharm)
sebesar 95,63% ± 1,145% dan tablet namadagang Tensivask® (DexaMedika)
sebesar 94,74% ± 2,70%, Normoten® (Soho) sebesar 94,94% ± 1,81%, Lopiten®
(Guardian Pharmatama) sebesar 96,54% ± 0,90%.
Hasilpenelitianmenunjukkankadaramlodipindalamsediaan
tablet
generikdannama
dagangmemenuhipersyaratan
tablet
padaumumnyayaitutidakkurang dari 90,0% dantidaklebih dari 110,0% darijumlah
yang terterapadaetiket.
Kata kunci : Amlodipin, penetapan kadar, spektrofotometri ultraviolet, validasi
metode
6
Universitas Sumatera Utara
Application of Ultraviolet Spectrophotometry Method on Determination of
Amlodipine Besilat in Tablet Preparations
Abstract
Amolodipine is one of antagonis calcium the group of dihidropiridin
which inhibit the entry of calcium ions through the membrane into the vascular
smooth muscle and cardiac muscle. The purpose of this study to find an
alternative method to determination of amlodipine tablets which are relatively
cheap and easy in implementation, but it gives results with good accuracy and
precision and olso to determine the levels of amlodipine tablet generic and trade
names on the market.
The name as the method which is used to the study is ultraviolet of
spectrophotometry with solvent of methanol at a wavelength of 364 nm. This
method meets the requirements validation test with the recovery percent is
100,51% and deviation standard of relative (RSD) is 3,7975%, detection of limit
(LOD) is, 1.5587 g/ml and quantitation of limit (LOQ) is, 5.1957 g/ml.
From the study were obtained the generic rate of amlodipine tablets
(Hespharm) equal to 95.63% ± 1.145% and the trade names Tensivask® tablets
(Dexa Medika) equal to 94.74% ± 2.70%, Normoten® (Soho) equal to 94.94% ±
1.81%, Lopiten® (Guardian Pharmatama) amounted to 96.54% ± 0.90%.
The study showed that levels of amlodipine in tablet dosage generic and
trade name meets the requirements of tablets in the general are not less than
90.0% and not more than 110.0% of the listed amount on the label.
Key words:amlodipine, determination, spectrophotometry ulraviolet, validation
methods.
7
Universitas Sumatera Utara