”Drug Substance Quantification AndValidation In Granisetron Film Coated Tablets ”


Türker A., Karaderi S.

2nd International Eurasian Conference on Biological and Chemical Sciences, İstanbul, Türkiye, 26 - 29 Haziran 2019, ss.865

  • Basıldığı Şehir: İstanbul
  • Basıldığı Ülke: Türkiye
  • Sayfa Sayıları: ss.865

Özet

Abstract

The 5-HT3 antagonists, informally known as "setrons", are a class of drugs that act as receptor antagonists at the 5-

HT3 receptor, a subtype of serotonin receptor found in terminals of the vagus nerve and in certain areas of the brain.

They are particularly effective in controlling the nausea and vomiting produced by cancer chemotherapy and are

considered the gold standard for this purpose. The molecules in this group are Granisetron, Tropisetron and

Ondansetron. Granisetron is a serotonin 5-HT3 receptor antagonist used as an antiemetic to tret nausea and vomiting

following chemotherapy and radiotherapy. Its main effect is to reduce the activity of the vagus nerve, wich is a nerve

that activates the vomiting center in the medulla oblongata. Granisetron was developed by chemists working at the

british drug company Beecham around 1988 and is available as a generic. In this study, a Reverse Phase-HPLC

method was developed and validated for the quantitation of Granisetron drug substance contained in the

commercially produced Emetril 1,00 mg Film Tablet. In order to determine granisetron drug substance from the

pharmaceutical preparation in solvent medium, analytical method was developed by using Reverse Phase-HPLC

method. By applying all validation parameters to the developed analytical method, the reliability of the method was

tested and the results were found to be within the validation limits. As a result, an accurate, sensitive, reliable and

reproducible method was developed and validated with HPLC method for Emetril Film Tablet containing

Granisetron drug substance.