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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
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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
