Pengembangan dan Validasi Metode Analisis Klorfeniramin Maleat Dalam Tablet dengan Metode Absorbansi dan Luas Daerah di Bawah Kurva Secara Spektrofotometri Ultraviolet

  • Harrizul Rivai
  • Mia Larasaky
  • Zikra Azizah

Abstract

A simple, precise and accurate method of analysis for the determination of chlorpheniramine maleate levels in tablets using absorbance method and the area under the curve by ultraviolet spectrophotometry has been developed and validated. This analysis was developed using various solvents, namely 0.1 N hydrochloric acid, 0.1 N sodium hydroxide, and distilled water. The results showed that the best solvent for chlorpheniramine maleate analysis was 0.1 N hydrochloric acid at a wavelength of 264.40 nm. The calibration curve shows a straight line in the concentration range of 10 - 26 μg/mL with a correlation coefficient of 0.9996, the detection limit of 0.612 μg/mL, the quantitative limit of 2.041 μg/mL by the absorbance method. The area under the curve method shows a straight calibration curve at the concentration range of 10 - 26 μg/mL with a correlation coefficient of 0.9990, the detection limit of 0.972 μg/mL, the quantitative limit of 3.239 μg/mL. Levels of generic chlorpheniramine maleate tablets with absorbance method and area under the curve were 98.667% and 97.483%, respectively. Levels of chlorpheniramine maleate patent tablets with absorbance method and area under the curve were 100.667% and 99.217%, respectively. The results of the assay obtained by the absorbance method and area under the curve method fulfill the requirements in accordance with the Pharmacopoeia of Indonesia edition V of 93-107%.

References

Al-Shaalan, N.H. (2010). Determination of phenylephrine hydrochloride and chlorpheniramine maleate in binary mixture using chemometric-assisted spectrophotometric and high-performance liquid chromatographic-UV methods. Journal of Saudi Chemical Society,14, 15–21.

Harmita. (2004). Petunjuk pelaksanaan validasi metode dan cara perhitungannya. Majalah Ilmu Kefarmasian, 1(3), 117-135.

Jones, D. S. (2010). Statistik Farmasi. Penerjemah: H. U. Ramadaniati & H. Rivai. Jakarta: Penerbit Buku Kedokteran EGC.

Kaura, A., Gupta, V., Roy, G.S. & Kaura, M. (2013). Spectrophotometric determination of chlorpheniramine maleate and phenylpropanolamine hydrochloride in dosage forms. International Current Pharmaceutical Journal, 2(5), 97-100.

Kementerian Kesehatan Republik Indonesia. (2014). Farmakope Indonesia. (Edisi 5). Jakarta: Kementerian Kesehatan Republik Indonesia.

Riadi, E. (2016). Statistika Penelitan (Analisis Manual dan IBM SPSS). Yogyakarta: Penerbit Andi.

Rohman, A. (2016). Validasi dan Penjaminan Mutu Metode Analisis. Cetakan Kedua. Yogyakarta: Gadjah Mada University Press.

Sjamsudin, U. (1989). Histamin dan antialergi. In S. Gan., R. Setiabudy., U. Sjamsudin & Z.S. Bustami (Eds.). Farmakologi dan terapi (pp. 222-233). Jakarta: Bagian Farmakologi Fakultas Kedokteran UI.

Yamato, S., Sakai, M. & Shimada, K. (1996). Quantitative analysis of chlorpheniramine maleate in cough and cold drugs by ion-pair high-performance liquid chromatography for the simultaneous determination of chlorpheniramine and maleate. Yakugaku Zasshi, 116(4), 329-34.
Published
2017-12-27
How to Cite
RIVAI, Harrizul; LARASAKY, Mia; AZIZAH, Zikra. Pengembangan dan Validasi Metode Analisis Klorfeniramin Maleat Dalam Tablet dengan Metode Absorbansi dan Luas Daerah di Bawah Kurva Secara Spektrofotometri Ultraviolet. Jurnal Sains dan Teknologi Farmasi, [S.l.], v. 19, n. Supl1, p. s58-s63, dec. 2017. ISSN 2580-5959. Available at: <http://jstf.ffarmasi.unand.ac.id/index.php/jstf/article/view/100>. Date accessed: 19 july 2018.