PENETAPAN KADAR RACIKAN KAPSUL YANG MENGANDUNG AMINOFILIN, CTM, DAN PREDNISON
Keywords:
assay, compounding capsule, aminophylline, CTM, prednisone
Abstract
The assay of active pharmaceutical ingredients (API) of compounding preparation is needed to assure the effectivity and safety of the pharmaceutical therapy. This research aims to assay determination of API in compounding capsules of aminophylline, chlorpheniramine maleate (CTM), and prednisone. The assay is done by UV spectrophotometry with Partial Least Square (PLS) multivariate calibration to thirty compounding capsules taken from Apotek “X” in Sleman. The result of the assay of aminophylline is 56,983% - 137,89%, CTM - 159,59% - 131,01%, and prednisone 32,31% - 245,79%. The Farmakope Indonesia 6th Edition assay requirement of aminophylline is 93,0% – 107,0%; CTM 90,0% - 110,0%; and prednison 90,0% - 110,0% of the label amount. The result shows that thirty samples of compounding capsules don’t meet the requirements stated by Farmakope Indonesia 6th Edition.
References
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2. Ali A, Ahmed M, Mahmud T, Qadir MA, Nadeem K, Saleem A. Stability-indicating High-performance liquid chromatography method for simultaneous determination of aminophylline and chlorpheniramine maleate in pharmaceutical formulations. Indian Journal of Pharmaceutical Sciences. 2015;77(5):515-521. doi:10.4103/0250- 474X.169042
3. Glavanović S, Glavanović M, Tomišić V. Simultaneous quantitative determination of paracetamol and tramadol in tablet formulation using UV spectrophotometry and chemometric methods. Spectrochimica Acta - Part A: Molecular and Biomolecular Spectroscopy. 2016;157:258-264. doi:10.1016/j.saa.2015.12.020
4. Dzulfianto A, Riswanto FDO, Rohman A. The employment of UV-spectroscopy combined with multivariate calibration for analysis of paracetamol, propyphenazone and caffeine. Indonesian Journal of Pharmacy. 2017;28(4):191-197. doi:10.14499/indonesianjpharm28iss4pp191
5. Primaharinastiti R, Helwandi IR. Three-Wavelength Spectrophotometric Method Validation for Determination of Prednisone Tablet. Proceeding International Conference on Medicine and Health Sciences (ICMHS). Published online 2016:39-42.
6. Darwish HW, Metwally FH, El Bayoumi A. Development of three methods for simultaneous quantitative determination of chlorpheniramine maleate and dexamethasone in the presence of parabens in oral liquids. Tropical Journal of Pharmaceutical Research. 2015;14(1):153-161. doi:10.4314/tjpr.v14i1.22
7. Rácz A, Bajusz D, Héberger K. Chemometrics in Analytical Chemistry.; 2018. doi:10.1002/9783527806539.ch9
8. Christin D, Putri A, Gani MR, Octa FD. Chemometrics-Assisted UV Spectrophotometric Method for Simultaneous Determination of Paracetamol and Tramadol in Divided Powder Dosage Form. 2021;13(1):1901-1907.
9. Rohman A, Irnawati, Dika F. KEMOMETRIKA. Vol Pertamn.
10. Rahayu P, Chaniago Y. Keseragaman Bobot Resep Racikan Serbuk Bagi (Pulveres) Di Apotek Kota Bandar Lampung Tahun 2017. Jurnal Analis Kesehatan. 2019;8(1):13. doi:10.26630/jak.v8i1.1642
11. Iskandar B. Uji Keragaman Bobot Pulveres untuk Penyakit Infeksi Saluran Pernapasan Akut (ISPA) pada Apotek di Wilayah Kerja Unit Pelayanan Teknis Puskesmas Bengkalis. Jurnal Penelitian Farmasi Indonesia. 2020;9(1):21-26. doi:10.51887/jpfi.v9i1.797
12. Santosa OB, Gani MR, Yuliani SH. Chemometric assisted quantitative determination of vitexin in ethanolic extract of binahong (Anredera cordifolia (ten.) steenis) leaves. International Journal of Applied Pharmaceutics. 2020;12(6):69-75. doi:10.22159/ijap.2020v12i6.39248
13. Suhandy D, Yulia M. The Use of Partial Least Square Regression and Spectral Data in UV-Visible Region for Quantification of Adulteration in Indonesian Palm Civet Coffee. International Journal of Food Science. 2017;2017. doi:10.1155/2017/6274178
14. Rohman A, Gupitasari I, Purwanto, et al. Quantification of lard in the mixture with olive oil in cream cosmetics based on FTIR spectra and chemometrics for Halal authentication. Jurnal Teknologi (Sciences and Engineering). 2014;69(1):113-119. doi:10.11113/jt.v69.2062
15. Rohman A, Che Man YB. Analysis of Lard in Cream Cosmetics Formulations Using FT- IR Spectroscopy and Chemometrics. Middle-East Journal of Scientific Research. 2011;7(5):726-727. https://pdfs.semanticscholar.org/fe0d/16489d5f0612e177a1dc94e6ebdffffc201d.pdf
16. Yuliantini A, Yuristina H, Tursino. Penetapan Kadar Pseudoefedrin Hcl Dan Klorfeniramin Maleat Dengan Metode Spektrofotometri Derivatif Dalam Sediaan Sirup. Farmagazine. 2018;5(2):23-30.
Published
2022-06-21
Section
Articles
