Abstract
A novel stability-indicating RP-HPLC assay method was developed and validated for quantitative determination of rebamipide in bulk and tablet dosage form. Rebamipide (drug and drug product) solutions were exposed to acid and alkali hydrolysis, thermal stress, oxidation by hydrogen peroxide and photodegradation. Experimental design has been used during forced degradation to determine significant factors responsible for degradation and to obtain optimal degradation conditions. In addition, acid and alkali hydrolysis was performed using a microwave oven. The chromatographic method employed the HiQ sil C-18HS (250 × 4.6 mm; 5 μm) column with mobile phase consisting of 0.02 M potassium phosphate (pH adjusted to 6.8) and methanol (40:60, v/v) and the detection was performed at 230 nm. The procedure was validated for specificity, linearity, accuracy, precision and robustness. There was no interference observed of excipients and degradation products in the determination of the active pharmaceutical ingredient. The method showed good accuracy and precision (intra and inter day) and the response was linear in a range from 0.5 to 5 μg mL−1. The method was found to be simple and fast with less trial and error experimentation by making use of experimental design. Also, it proved that microwave energy can be used to expedite hydrolysis of rebamipide.
Highlights
Forced degradation is an integral part of drug development process
It is necessary to plan the experiments in such a way that the real experimental situation as well as the theoretical background of experiments is obtained
The aim of this study was to develop and validate stability-indicating LC method for quantification of rebamipide in bulk and tablets according to official codes
Summary
Forced degradation is an integral part of drug development process. most of the literature defines the concept of forced degradation they do not provide detailed information about a forced degradation strategy [1, 2]. The experimental conditions to conduct forced degradation are described in a general way [3, 4] but exact stress conditions to be applied are not described. A trial and error approach is adopted to select the strength, temperature and time of exposure to achieve degradation to an extent of 10–20% [5]. Such trial and error approach is cost, time and labor intensive and should be substituted by more systematic approaches. It is necessary to plan the experiments in such a way that the real experimental situation as well as the theoretical background of experiments is obtained
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
