Comparative Degradation Study of Different Brands of Rabeprazole Tablet Using UV- Spectrophotometer
[1]
Md. Jakaria, Department of Pharmacy, International Islamic University Chittagong (IIUC), Chawkbazar, Chittagong, Bangladesh.
[2]
Abul Hasanat, Department of Pharmacy, International Islamic University Chittagong (IIUC), Chawkbazar, Chittagong, Bangladesh.
[3]
Md. Adnan, Department of Pharmacy, International Islamic University Chittagong (IIUC), Chawkbazar, Chittagong, Bangladesh.
[4]
Md. Nazim Uddin Chy, Department of Pharmacy, International Islamic University Chittagong (IIUC), Chawkbazar, Chittagong, Bangladesh.
[5]
Awale Yusuf Mousa, Department of Pharmacy, International Islamic University Chittagong (IIUC), Chawkbazar, Chittagong, Bangladesh.
The objective of this study was to develop the degradation studies of different brands of rabeprazole available in market. Forced degradation is a process that involves degradation of drug products and drug substances at conditions more severe than accelerated conditions and thus generates degradation products that can be studied to determine the stability of the molecule. Different brands available for rabeprazole sodium, is a most prescribed an anti-ulcer drug in the class of proton pump inhibitors and it has proven efficacy in healing, symptom relief and prevention of relapse of gastric ulcer, duodenal ulcer and gastro-oesophageal reflux disease. This drug was subjected to different stress conditions as per International Conference on Harmonization guidelines (ICH). An ultraviolet UV spectroscopic method was developed for analysis of the drug in the presence of the degradation products. Distilled water was used as a solvent. The amount of degraded drugs was calculated by taking the absorbance at 284 nm. According to the assay limit of USP specified that the content should not be less than 95% and not more than 105% of labelled amount. In case of effect acidic pH, only Rasonix 20 and Rabe 20 was stable. But in case effect of basic pH all brands of rabeprazole were more or less degraded. In addition to heat exposure only Rasonix 20 was stable, but other brands were also degraded. It was concluded that only one brand, Rasonix 20 showed accepted results among other brands of acidic and heat effect from ranges for all the stresses applied for degradation studies.
Rabeprazole, anti-Ulcer, degradation studies, assay, USP
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