生物学的同等性とバイオアベイラビリティのジャーナル

概要

Degradation Study of Metronidazole in Active and Different Formulation by UV Spectroscopy

Safila Naveed, Nimra Waheed and Safeena Nazeer

Metronidazole (MTZ) is a 5-nitroimidazole semi-synthetic compound. MTZ is antiamoebic, anti protozoal and antibacterial, anti parasitic and anti trichomonal agents. It has wide range of activity against anaerobic bacteria as gram negative, gram positive bacilli and cocci, certain capnophilic organisms, protozoa and parasites. It is indicated in infections caused by Helicobacter pylori, acne rosacea, anaerobic infections, parasitic infections, pseudomembranous colitis and Crohn’s disease. ICH guidelines states the parameters which causes forced degradation of a drug product includes Time, Temperature and/ or with humidity, Acid/base Stress testing, photo degradation and pH variation (high and low). Ultraviolet-visible spectroscopic process was developed to analyze and calculate the amount of drug in the presence of degradation products. According to the USP, the official assay limit of the content should NLT 90% and NMT 110% of labeled amount of metronidazole. When active of metronidazole and different brands (FGL, MNE, KNT) exposed to acidic medium of 1N HCl FGL, MNE and KNT show heavy degradation whereas as active MTZb didn’t show any degradation. When active of metronidazole and FGL, MNE, KNT exposed to basic medium i.e. 1N NaOH, FGL show moderate degradation, MNE and KNT shows slight degradation whereas as active didn’t show any degradation. FGL, MNE, KNT and ND MTZb when subjected to heat none of them show degradation. When MTZb, FGL, MNE and KNT subjected to UV light, MTZb exhibit heavy degradation whereas FGL, MNE and KNT exhibit no degradation. UV-Vis spectroscopy is a simple, rapid, cost effective, useful and fruitful method for determination of MTZ in their active and pharmaceutical dosage form (tablets) of different brands.