Penetapan Kadar Campuran Teofilin dan Efedrin Hidroklorida dalam Sediaan Tablet dengan Metode Spektrofotometri Derivatif

PENETAPAN KADAR CAMPURAN TEOFILIN DAN EFEDRIN
HIDROKLORIDA DALAM SEDIAAN TABLET DENGAN METODE
SPEKTROFOTOMETRI DERIVATIF
ABSTRAK
Campuran teofilin dan efedrin HCl merupakan salah satu jenis kombinasi
dalam sediaan tablet. Penetapan kadar tablet campuran teofilin dan efedrin HCl
tidak terdapat dalam monografi, baik pada Farmakope Indonesia edisi V (2014)
maupun United States Pharmacopeia 30 and The National Formulary 25 (USP
30-NF 25) (2007) sehingga diperlukan suatu metode analisis yang memenuhi uji
validitas pada penetapan kadarnya. Tujuan penelitian ini adalah untuk menguji
validasi metode spektrofotometri derivatif dalam menetapkan kadar campuran
teofilin dan efedrin HCl dalam sediaan tablet.
Metode penelitian yang dilakukan adalah pengambilan sampel secara
purposif terhadap campuran tablet teofilin dan efedrin HCl yaitu tablet
Grafasma® (PT. Graha Farma) dan Ifasma® (PT.Ifars) dan penetapan kadar
secara spektrofotometri derivatif metode zero crossing dalam pelarut HCl 0,1 N.
Hasil penelitian menunjukkan bahwa kadar teofilin pada tablet
Grafasma® (99,89 ± 1,67) % dan Ifasma® (99,35 ± 2,74)% dan kadar efedrin
HCl pada sampel Grafasma® (98,88± 3,21) % dan Ifasma® (96,59 ± 2,32) %.
Dari hasil analisis penetapan kadar sampel campuran teofilin dan efedrin HCl
dalam sediaan tablet menunjukkan teofilin memenuhi persyaratan kadar

untuk sediaan tablet teofilin tunggal menurut USP 30-NF 25 (2007) dan efedrin
HCl memenuhi persyaratan kadar tunggal menurut Farmakope Indonesia edisi V
(2014). Hasil uji validasi yang dilakukan terhadap tablet Grafasma (PT. Graha
Farma), untuk teofilin diperoleh persen perolehan kembali = 99,67%, RSD =
1,07% dan untuk efedrin HCl diperoleh persen perolehan kembali = 100,07%,
RSD =1,07%.
Berdasarkan hasil penelitian yang dilakukan maka metode
spektrofotometri derivatif dapat digunakan untuk menetapkan kadar teofilin dan
efedrin HCl dalam tablet pada derivat kedua. Penetapan kadar dengan metode
spektrofotometri derivatif memenuhi persyaratan akurasi dan presisi.
Kata kunci: Teofilin, Efedrin HCl, Spektrofotometri Derivatif, Zero Crossing,
Derivat Kedua, Validasi

vi
Universitas Sumatera Utara

DETERMINATION OF THEOPHYLLINE AND EPHEDRINE HCl
MIXTURE IN TABLETS BY DERIVATIVE SPECTROPHOTOMETRIC
METHOD
ABSTRACT

The mixture of theophylline and ephedrine HCl is one of combination in
tablet . Determination of content of theophylline and ephedrine HCl in tablet
there is no in monography, either in the fifth edition Farmakope Indonesia (2014)
or United States Pharmacopeia 30 and The National Formulary 25 (USP 30-NF
25) (2007) that requires an analysis method that meets the test of validity in
determining the content. The aim of this study was to test the validation of
derivative spectrophotometric method in determination the content theophylline
and ephedrine HCl in tablets.
The method of this research was done by purposive sampling to
theophylline and ephedrine HCl mixture of the sample Grafasma® and Ifasma® in
tablets content using derivative spectrophotometric with zero crossing technique
and determination in HCl 0,1N.
The research results were obtained the theophylline and ephedrine HCl
content of the sample Grafasma® tablets were (99.89 ± 1.67) % and (99.35 ±
2.74) % and ephedrine HCl content of the sample Grafasma® tablets (98.88±
3.21) % and Ifasma® (96.59 ± 2.32) %. Based on the results of analysis
determine the sample content of theophylline and ephedrine HCl compound in
tablet supply theophylline fulfilled the requirements in USP 30-NF 25 (2007) and
ephedrine HCl fulfilled the requirement of tablet in Farmakope Indonesia V
(2014). The results of validation test on the tablet of Grafasma (PT. Graha

Farma), the percent recovery for theophylline is 99.67%, relative standard
deviation (RSD) = 1.07% and for ephedrine HCl, the percent recovery =
100.07%, RSD = 1.07%.
Based on the results of research, that derivative spectrophotometric
method can be used to determination of theophylline and ephedrine HCl in the
tablets at the second derivate. Assay of the derivative spectrophotometric method
meet the requirements of accuracy and precision.
Keywords: Theophylline, Ephedrine HCl, Derivative Spectrophotometric, Zero
Crossing, Second Derivatives, Validation

vii
Universitas Sumatera Utara