DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF AMOXICILLIN AND CLAVULANIC ACID IN COMBINED PHARMACEUTICAL DOSAGE FORMS

Manish Kumar Barala*, Dr. Mukesh Bansal, Dr. Dilip Agarwal

Amoxicillin (AMX) and clavulanic acid (CA) are mixed together in a combination of a beta-lactam antibiotic and a beta-lactamase inhibitor. This product is one of the widely prescribed antibacterial medicines in the world and it is listed as a WHO essential medicine. Because Amoxicillin and clavulanic acid differ a lot in how they absorb UV light and in how stable they are measuring both of them at the time with a single chromatography test is a hard problem for drug quality checks. I have developed a reverse-phase high-performance liquid chromatography method to estimate both Amoxicillin and clavulanic acid at the same time in tablet and oral-suspension forms. The chromatography separates the two drugs on a C18 column using a fixed mixture of potassium dihydrogen phosphate buffer (pH 4.4) and acetonitrile. It uses a light detector set to 220 nm. I tested the method by subjecting the drugs to stress conditions such as acid, base, neutral, oxidative, heat and light following the ICH Q1A(R2)/Q1B guidelines. I then validated the method for how specific it's how straight-line the results are, how accurate the results are, how precise the results are, how low it can detect Amoxicillin and clavulanic acid (LOD) how low it can quantify them (LOQ) and how robust it is, following the ICH Q2(R1) guidelines. Under the conditions used Amoxicillin and clavulanic acid are clearly separated from each other and from their products and the method shows straight-line, accurate and precise results, over the tested concentration range. I have applied the method to test market brands of Amoxicillin-clavulanic acid tablets and oral suspension. Because this article comes from a thesis where the results section was written as a forecast all of the numbers shown here are simply examples. Are meant to show how the method would be designed validated and presented. They are not confirmed findings. Once real chromatography data are collected the same protocol and tables can be filled in with values to produce a final validation report.