Validasi Metode Analisis Raw Material Clonazepam Menggunakan GC-MS MPS

Putrimarsana, Dhevy Indah Warap Sari (2023) Validasi Metode Analisis Raw Material Clonazepam Menggunakan GC-MS MPS. Other thesis, Institut Teknologi Sepuluh Nopember.

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Abstract

Clonazepam merupakan golongan obat bezodiazepin yang bekerja dengan meningkatkan ingibisi neuron atau disebut neurotransmitter pada GABA di otak dan menimbulkan efek menenangkan serta euforia pada penggunanya sehingga sering disalahgunakan dan menjadi keresahan masyarakat. Oleh karena itu, suatu metode dikembangkan dan divalidasi untuk mendeteksi dan mengkuantifikasi senyawa Clonazepam. Metode ini dilakukan dengan kuantifikasi target analit berdasarkan konsentrasi dengan varisai 0; 1; 2; 3; 4; 5; 6; 7; 8; 9; dan 10 ppm sebanyak 10 kali replikasi pada setiap variasi konsentrasi yang diuji. Seluruh pengujian dilakukan menggunakan modifikasi instrumen GC-MS dengan tambahan perangkat MPS sehingga perlu dilakukan validasi untuk menilai kinerja alat serta kecocokan dengan syarat keberterimaan parameter uji metode analisis untuk mendapatkan hasil analisis Clonazepam yang andal,cepat, akurat, efisien, dan terpercaya. Parameter validasi metode pengujian yang digunakan pada penelitian ini meliputi linearitas, LOD, LOQ, presisi, akurasi, dan selektifitas. Hasil pengujian metode analisis diperoleh koefisien determinasi (R2) sebesar 0,9985; LOD sebesar 0,22 mg/L; LOQ sebesar 0,23 mg/L; akurasi sebesar 101,32%; presisi dengan rata-rata konsentrasi terukur dan standar deviasi sebesar 2,4391±0,0218; % RSD sebesar 0,89 %; dan resolusi (Rs) sebesar 3,4856. Metode analisis pada penelitian Tugas Akhir ini dapat dinyatakan valid karena parameter validasi metode seperti, linearitas, LOD, LOQ, presisi, akurasi, dan selektivitas memenuhi syarat keberterimaan.
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Clonazepam is a benzodiazepine drug that works by increasing the inhibition of neurons or neurotransmitters GABA in the brain, this causes a calming and euphoric effect on users. It is often abused and causes concern in society. Therefore, a method was developed and validated to detect and quantify Clonazepam compounds. This method was performed by quantifying the target analyte based on concentration variations 0; 1; 2; 3; 4; 5; 6; 7; 8; 9; and 10 ppm, with 10 replications for each concentration variation tested. All tests were performed using a modified GC-MS instrument with the addition of an MPS device, therefore validation was necessary to assess the performance of the tool and its suitability with the acceptance criteria of the analytical method test parameters to obtain reliable, fast, accurate, efficient, and trustworthy analysis results. The validation of analytical method parameters used in this research include linearity, LOD, LOQ, precision, accuracy, and selectivity. The results of the analysis method testing obtained a coefficient of determination (R2) is 0.9985; LOD is 0.22 mg/L; LOQ is 0.23 mg/L; accuracy is 101.32%; precision with an average measured concentration and standard deviation is 2.4391±0.0218; % RSD is 0,89%; and resolution (Rs) is 3.4856. The analysis method in this Final Project research can be declared valid because the method validation parameters such as linearity, LOD, LOQ, precision, accuracy, and selectivity suitable with the acceptance criteria.

Item Type:	Thesis (Other)
Uncontrolled Keywords:	Clonazepam, Benzodiazepin, GC-MS, MPS, Validasi Metode Analisis, Benzodiazepine, Validation of Analytical Method.
Subjects:	R Medicine > RM Therapeutics. Pharmacology > RM950 Rehabilitation technology. R Medicine > RS Pharmacy and materia medica
Divisions:	Faculty of Science and Data Analytics (SCIENTICS) > Chemistry > 47201-(S1) Undergraduate Thesis
Depositing User:	Dhevy Indah Warap Sari Putrimarsana
Date Deposited:	17 Feb 2024 07:44
Last Modified:	17 Feb 2024 07:44
URI:	http://repository.its.ac.id/id/eprint/107257

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