Validation of spectrophotometric method for quantification of cefazoline in simulated tear fluid and porcine ocular tissue from thermosensitive-mucoadhesive in situ ocular gel preparation

Abstract

In the formulation development, it is necessary to validate the analytical method as a critical step. Here, we validated the spectrophotometric method of cefazoline (CFZ) from thermosensitive-mucoadhesive in situ gels in simulated tear fluid (STF) and ocular tissue for in vitro and ex vivo studies, respectively. The method was validated as per ICH guidelines, showing excellent linearity with the correlation coefficient values of 0.9997 in STF and 0.9981 in ocular tissue with acceptable precision and accuracy. The LOD values were 0.496 µg/mL and 2.390 µg/mL in STF and ocular tissue, respectively. Moreover, LOQ values were 1.504 µg/mL in STF and 7.242 µg/mL in ocular tissue. The method was utilized in the in vitro and ex vivo studies, showing that the concentration of CFZ localized in the ocular tissue was significantly improved following its incorporation into thermosensitive mucoadhesive in situ gels. In vivo studies with suitable analytical method must be performed.