KPI-based standards benchmarking for the preference of different analytical approaches developed for simultaneous determination of ciprofloxacin and hydrocortisone: A SWOT case study

Abstract

This study aims to prefer the suitability of an analytical approach developed for simultaneously determining ciprofloxacin hydrochloride (CIP) and hydrocortisone (HYD) in their ear drop dosage form. The preference between the three known instruments was utilized, namely UV-spectrophotometry, reversed phase-high-performance liquid chromatography (RP-HPLC)-UV, and thin-layer chromatography (TLC)-densitometry. The instrumentational studies determined that the mathematical UV methods (utilized various manipulation designs such as the isoabsorptive point, absorbance ratio, extended ratio subtraction, ratio difference, and mean centering of ratio spectra) had linearities in the range of 2.0–14.0 and 1.0–14.0 µg·mL−1, the RP-HPLC-UV method showed a linearity range of 1.0–8.0 µg·mL−1, and the TLC-spectrodensitometric method had linearity ranges of 0.2–1.6 µg/band and 0.6–2.0 µg/band for both CIP and HYD, respectively. The analytical performance, validity, and greenness of the approaches were evaluated through the benchmarking of key performance indicator (KPI)-based standards and a SWOT (strengths, weaknesses, opportunities, and threats) analysis. The KPIs and SWOT study focused on several aspects, including (1) the selectivity and robustness of the methods, (2) sensitivity, (3) accuracy and precision, (4) applicability, (5) whiteness, (6) greenness, and (7) blueness. However, the assessment of whiteness, greenness, and blueness was conducted using well-known ecological assessment tools such as the RGB12 Algorithm, Analytical Eco-Scale, AGREE, GAPI, and Blue Applicability Grade Index. In conclusion, based on the findings, UV-spectrophotometry emerged as the most practically convenient approach. It demonstrated advantages based on the predetermined KPI-based standards. Furthermore, UV-spectrophotometry was deemed to be the most environmentally friendly option.