Jurnal Ilmiah Farmasi
Vol. 21 No. 1 (2025): Jurnal Ilmiah Farmasi

Forced Degradation and Stability Testing of Chloramphenicol Ear Drops Using Derivative Spectrophotometry Combining with Chemometrics

Rahmah, Annisa (Unknown)
Wijaya, Triyadi Hendra (Unknown)
Wasito, Hendri (Unknown)



Article Info

Publish Date
31 May 2025

Abstract

Background: Chloramphenicol eye drops have a lower stability than solid dosage forms. Hence, it is necessary to assess their stability. One stability test that can be conducted is the forced degradation approach, which involves applying stress conditions that are more severe than those used in accelerated stability testing.Objective: This study used forced degradation to explore the stability profile of chloramphenicol ear drops.Methods: Stability analysis was carried out using a derivative spectrophotometric instrument combined with chemometric analysis. The forced degradation study was conducted by exposing the sample to three conditions: acidic (0.1 N HCl at 80°C for 2 hours), alkaline (0.1 N NaOH at 80°C for 2 hours), and heat (90°C for 4 hours). Principal Component Analysis (PCA) and Partial Least Squares–Discriminant Analysis (PLS-DA) were utilized for the chemometric analysis. Results: Sequential chloramphenicol observations with a zero to third derivative show a maximum wavelength of 278, 260, 234, and 292 nm. According to stability studies with forced degradation, chloramphenicol tended to degrade under alkaline and thermal conditions compared to acidic conditions. A typical grouping pattern amongst forced degradation treatments is revealed by chemometric analysis, which characterizes chloramphenicol's stability profile under different experimental settings.Conclusion: The UV-Vis spectrophotometric approach, both non-derivative and derivative, can describe changes in chloramphenicol degradation profiles, although the specific degradation products generated remain unknown.

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Journal Info

Abbrev

JIF

Publisher

Subject

Medicine & Pharmacology

Description

JIF merupakan jurnal yang dikelola oleh Prodi Farmasi Universitas Islam Indonesia, dan diterbitkan dua kali dalam setahun. Jurnal ini dirancang sebagai sarana publikasi penelitian yang mencakup secara rinci sejumlah topik dalam bidang farmasi yang berkaitan dengan farmasi sains dan teknologi serta ...