Abstract
The simple and rapid spectrophotometric methods were developed for analysis of hydrocortisone acetate in cream pharmaceutical formulations containing nipagin as preservative. Concentration of hydrocortisone acetate was determined by measuring the first derivative absorption (ratio amplitudes) at 257.0 nm (zero crossing for nipagin). The calibration graphs were linear over the range of 4.0-40.0 ppm of hydrocortisone acetate (r= 0.9999). The limit of detection (LOD) and the limit of quantitation (LOQ) were found to be 0.9617 ppm and 3.2050 ppm, respectively. This method had good precision (repeatability and intermediate precision) with RSD < 2.0% where as the means of the recovery data (accuracy) were 102.03±0.14% and 100.23±0.69% for hydrocortisone acetate cream 1% and 2.5%, respectively. The proposed method was applied for the determination of hydrocortisone acetate in three out of four commercial cream formulations samples and the results of label claim were 102.93±0.22%, 108.48±0.19% and 106.67±0.35% for sample A, B and D, respectively. The result of brand C analysis showed to contain more than 110.0% of the labeled amount of hydrocortisone acetate, indicated there was additive other than nipagin in the cream basis to interfer with the hydrocortisone acetate measurements.
Bahasa Abstract
Metode spektrofotometri yang sederhana dan cepat telah dikembangkan untuk analisis hidrokortison asetat dalam sediaan farmasi krim mengandung nipagin sebagai pengawet. Hidrokortison asetat ditentukan dengan mengukur serapan derivat pertama (rasio amplitudo) pada 257,0 nm (zero crossing nipagin). Kurva kalibrasi menunjukkan linier pada rentang 4,0-40,0 ppm hidrokortison asetat (r= 0,9999). Limit deteksi (LOD) dan limit kuantitasi (LOQ) diperoleh masing-masing 0,9617 ppm dan 3,2050 ppm. Metode ini mempunyai presisi yang baik (keterulangan dan presisi intermediet) (RSD <2,0%), sedangkan rerata data hasil uji perolehan kembali (accuracy) adalah 102,03±0,14% dan 100,23±0,69%, masing-masing untuk hidrokortison asetat krim1% dan 2,5%. Metode ini berhasil diterapkan untuk penetapan kadar hidrokortison asetat tiga dari empat sampel sediaan merk dagang dan hasilnya adalah 102,93±0.22%, 108,48±0,19% dan 106,67±0,35%, masing-masing untuk sampel A, B dan D. Hasil analisis sampel C menunjukkan kadar hidrokortison asetat lebih dari 110,0% dari yang tertulis pada labelnya, mengindikasikan adanya bahan tambahan lain selain nipagin dalam basis krimnya yang menginterferensi pengukuran hidrokortison asetat.
Recommended Citation
Hayun, Hayun; Leswara, Nelly D.; and Zarkasih, Lutfhi
(2014)
"Penetapan Kadar Hidrokortison Asetat dalam Sediaan Krim Mengandung Pengawet Nipagin secara Spektrofotometri Derivatif Orde Pertama,"
Pharmaceutical Sciences and Research: Vol. 1:
No.
2, Article 4.
DOI: 10.7454/psr.v1i2.3495
Available at:
https://scholarhub.ui.ac.id/psr/vol1/iss2/4
