ATR-FTIR spectroscopy methods for determination of aminoglycoside antibiotics in ophthalmic and parenteral preparations with full partial least squares algorithm

Attenuate Total Reflectance-Fourier Transform Infrared (ATR-FTIR) Spectroscopy methods were developed and validated for the analysis of selected aminoglycoside antibiotics (AGAs) as per ICH guidelines. This non-destructive technique was utilized as a direct measurement of sample after grinding to prepare the powder required priorto read on diamond reader of ATR-FTIR spectrophotometer. Dilutions were made using spectroscopic grade potassium bromide (KBr) on %w/w basis.Linear concentration ranges from 0.25-15.0 (%w/ w)were observed with high regression value (r2> 0.995)on their unique peak bands using full spectrum partial least squares (PLS)algorithm. These methods weredisplayed low limit of detection (LOD) of 0.20-0.25 (%w/w) and low limit of quantification (LOQ) of 0.60-0.80 (%w/w) for three selected AGAs (Gentamicin, Tobramycin and Kanamycin). The intra-day and inter-day precision values were found with %RSD less than 4.00.Assay studies were shown withtheir mean recovery estimated at 100.727 ± 2.65% for gentamicin, 101.04±1.076% for tobramycin, and 100.67% ±1.08%at 95% confidence intervals for the quantification of gentamicin and tobramycin in ophthalmic preparations and kanamycin in injections. These methods were found to be simple, faster, non-destructive with full sample recovery and eco-friendly. Hence, proposed ATR-FTIR spectroscopy methods can be used for routine analysis and samples approval for regulatory and therapeutic drug monitoring studies during treatment with AGAs with good precision and accuracy comparatively with conventional LC-MS methods, which are time consuming and complex method parameters and also needs dedicated space, funding, manpower and time consuming for immediate results.