DoE Guided Development of an HPLC Method for Evaluation of Amoxicillin and Metronidazole Co-loaded Mucoadhesive GRDDS Formulation for H. pylori Eradication

Ashutosh Gupta, Prerana D. Navti, Srinivas Mutalik, Moumita Saha, Sudheer Moorkoth

Research output: Contribution to journalArticlepeer-review

Abstract

H. Pylori infection is a major reason for chronic Peptic Ulcer Disease (PUD) and related complications worldwide. Traditional treatment options fail to eradicate the organism completely which leads to antibiotic resistance. Novel formulations are being developed with an aim for effective treatment. Mucoadhesive GRDDS system is an option to increase the antibiotic bioavailability. The objective of this work is to develop a RP-HPLC–PDA based analytical method to evaluate the entrapment efficiency of the GRDDS systems developed for H. pylori treatment containing amoxicillin and metronidazole. DoE was used for optimizing the HPLC conditions. The optimized method used a HyperClone ODS C18 column as stationary phase and methanol: phosphate buffer (15:85) at pH 6.4 as the mobile phase. The flow rate was 0.9 mL/min. Method was validated as per the ICH Q2(R1) guideline. Method was linear from 0.5 to 20 µg/ml for both amoxicillin and metronidazole with an R2 value of 0.9995 and 0.9996 respectively. The validated HPLC method showed specificity for both drugs in the presence of degradation products as well as from other excipients of the GRDDS system. The validated method was applied to determine the entrapment efficiency as a part of formulation optimization. The entrapment efficiency of the final formulation was determined to be 78–84% and 75–82% for amoxicillin and metronidazole respectively. Graphical Abstract: [Figure not available: see fulltext.].

Original languageEnglish
Pages (from-to)729-742
Number of pages14
JournalChromatographia
Volume86
Issue number11-12
DOIs
Publication statusPublished - 12-2023

All Science Journal Classification (ASJC) codes

  • Analytical Chemistry
  • Biochemistry
  • Clinical Biochemistry
  • Organic Chemistry

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