Aplikasi Fourier Transform Infrared Spectrophotometry dengan Kemometrika dalam Penetapan Kadar Kreatin Monohidrat pada Sediaan Floating Tablet
Anas Ardiana Wati, Apt. Marlyn Dian Laksitorini, M.Sc. PhD.; Dr. apt. Agustina Ari Murti Budi Hastuti, S.Farm., M.Sc.
2023 | Skripsi | FARMASI
Kreatin sebagai zat ergogenik mampu meningkatkan performa olahraga serta
berkhasiat dalam terapi penyakit neurodegeneratif. Berbagai teknik spektroskopi
hingga kromatografi telah diterapkan dalam analisis kreatin. Namun demikian, metode
kromatografi memerlukan solvent organik dan waktu yang lebih lama. Pengembangan
spektroskopi FTIR kombinasi kemometrika dipilih dengan pertimbangan proses yang
mudah, cepat, serta pendekatan green chemistry untuk mencapai SDGs 13 yaitu
climate action. Penelitian ini bertujuan untuk penetapan kadar kreatin monohidrat pada
sediaan floating tablet. Target kedepannya, penelitian ini dapat diterapkan dalam
analisis rutin keseragaman kadar sediaan pada proses produksi di industri farmasi.
Pendekatan kemometrika dilakukan dengan kalibrasi multivariat model PCR
dan PLS yang didesain menggunakan bantuan software TQ Analyst. Validasi metode
dilakukan dengan mengevaluasi parameter statistik berupa R2, RMSEC, RMSEP,
RMSECV. Koleksi data spektra FTIR dilakukan dengan software Thermo Scientific™
OMNIC™ Series. Visualisasi dan pemprosesan spektra dikerjakan dengan software
Origin 2023.
Hasil pemindaian spektra dioptimasi melalui aspek pemilihan daerah
wavenumber serta jenis spektra. Berdasarkan hasil parameter validasi dipilih model
PLS pada spektra normal dengan wavenumber 1650-1350 cm-1. Model ini memberikan
hasil R2 untuk kalibrasi, validasi, dan cross-validation sebesar 0,9983; 0,9985; 0,9977
serta nilai RMSEC, RMSEP, dan RMSECV yaitu 1,74; 1,72; 2,07. Penerapan metode
ini untuk penetapan kadar kreatin monohidrat dalam sediaan floating tablet
memberikan hasil konsentrasi sebesar 99,99 ± 1,04% yang telah memenuhi
persyaratan kadar kreatin pada monografi USP 44.
Creatine as an ergogenic substance can improve sports performance and treat
neurodegenerative diseases. Various spectroscopic to chromatographic techniques
have been applied in the analysis of creatine. However, the chromatographic method
requires organic solvents and a longer time. The development of FTIR spectroscopy
with chemometrics was chosen because of an easy and fast process with consideration
of the green chemistry approach to achieve SDGs 13 (climate action). This study aims
to determine the levels of creatine monohydrate in floating tablet preparations. This
research can be applied in the routine analysis of dosage uniformity in production
processes in the pharmaceutical industry.
The chemometric approach was carried out by multivariate calibration of the
PCR and PLS models which were designed using TQ Analyst software. Method
validation was carried out by evaluating the statistical parameters of R2, RMSEC,
RMSEP, and RMSECV. FTIR spectral data collection was performed with the Thermo
Scientific™ OMNIC™ Series Software. Spectral visualization and processing were
done with the Origin 2023 software.
The results of the spectral scanning are optimized through the aspect of
wavenumber area and the type of spectra. Based on the results, the PLS model was
selected in the normal spectra with a wavenumber of 1650-1350 cm-1. This model gives
R2 results for calibration, validation, and cross-validation of 0.9983; 0.9985; 0.9977
and the RMSEC, RMSEP, and RMSECV values are 1.74; 1.72; 2.07. The application
of this method for determining creatine monohydrate content in floating tablet gave a
concentration of 99.99 ± 1.04% which met the requirements for creatine levels in USP
44 monograph.
Kata Kunci : kreatin monohidrat, floating tablet, FTIR, kemometrika