Analytical study of amoxicillin and metronidazole co-loaded pharmacosomes for H. pylori eradication using DoE-based modeling of an HPLC-PDA technique

Ashutosh Gupta,  Moumita Saha,  Shivani Kunkalienkar,  Abhishek Jha,  Pranav Kulkarni,  Megha Samanth,  Sathvik Chennamsetty,  Princia Annie Dsouza,  Srinivas Mutalik,  Sudheer Moorkoth   

Ashutosh Gupta1, Moumita Saha1, Shivani Kunkalienkar1, Abhishek Jha2, Pranav Kulkarni1, Megha Samanth1, Sathvik Chennamsetty1, Princia Annie Dsouza1, Srinivas Mutalik3, Sudheer Moorkoth1

1Department of Pharmaceutical Quality Assurance, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India.

2Department of Pharmaceutics, Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, India.

3Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal 576104, Karnataka, India.

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Published:  Apr 20, 2025

DOI: 10.7324/JAPS.2025.226214
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Abstract

Treating Helicobacter pylori (H. pylori) infection is challenging for the doctor due to the peculiar pathophysiology of bacteria that leads to antibiotic resistance. Pharmacosome is a novel formulation that could be a promise in treating the infection because of its ability to improve the bioavailability of antibiotics. The objective of this study is to develop and validate an high performance liquid chromatography (HPLC) -based analytical technique to evaluate the stability, % entrapment efficiency (% EE), and the drug release of amoxicillin (AMX) and metronidazole (MEZ) co-loaded pharmacosomes. To illustrate the effect of this method clearly, the design of the experiment tool was used to model the HPLC method. The independent variables were buffer ratio, pH, flow rate, and injection volume. The responses were retention time, drug peak area, and resolution between the drugs. The optimized method was validated as per ICH Q2(R2) guidelines. The linearity was plotted in the 0.5–20 μg/ml range for both AMX and MEZ. The linear regression equation showed an R2 of more than 0.999, proving the linearity of the method. The method was used to check the stability, % EE, and % drug release of antibiotics in the pharmacosomes. The developed method’s accuracy was between 99%–102% for both AMX and MEZ. The inter-day and intra-day precision of the developed method was within the limit for both AMX and MEZ, the %CV was less than 2%. The HPLC method was selective, sensitive, linear, and eco-friendly, with an Analytical GREEnness Metric Approach and Software score of 0.66.


Keyword:     Helicobacter pylori amoxicillin metronidazole HPLC design of expert pharmacosomes modeling

Citation:

Gupta A, Saha M, Kunkalienkar S, Jha A, Kulkarni P, Samanth M, Chennamsetty S, Dsouza PA, Mutalik S, Moorkoth S. Analytical study of amoxicillin and metronidazole co-loaded pharmacosomes for H. pylori eradication using DoE-based modeling of an HPLC-PDA technique. J Appl Pharm Sci. 2025. Online First. http://doi.org/10.7324/JAPS.2025.226214

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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