Saleh S.S.Lotfy H.M.Hassan N.Y.Elgizawy S.M.Analytical Chemistry DepartmentFaculty of PharmacyOctober University for Modern Sciences and Arts (MSA)11787 6th October CityEgypt; Analytical Chemistry DepartmentFaculty of PharmacyCairo UniversityKasr-El Aini Street11562 CairoEgypt; Analytical Chemistry DepartmentFaculty of PharmacyAssuit University71515 AssuitEgypt2020-01-092020-01-09201313190164https://doi.org/10.1016/j.jsps.2012.11.001PubMed ID :https://t.ly/KXMGpScopusMSA Google ScholarThe determination of sodium cromoglicate (SCG) and fluorometholone (FLU) in ophthalmic solution was developed by simple, sensitive and precise methods. Three spectrophotometric methods were applied: absorptivity factor (a-Factor method), absorption factor (AFM) and mean centering of ratio spectra (MCR). The linearity ranges of SCG were found to be (2.5-35?g/mL) for (a-Factor method) and (MCR); while for (AFM), it was found to be (7.5-50?g/mL). The linearity ranges of FLU were found to be (4-16?g/mL) for (a-Factor method) and (AFM); while for (MCR), it was found to be (2-16?g/mL). The mean percentage recoveries/RSD for SCG were found to be 100.31/0.90, 100.23/0.57 and 100.43/1.21; while for FLU, they were found to be 100.11/0.56, 99.97/0.35 and 99.94/0.88 using (a-Factor method), (AFM) and (MCR), respectively. A TLC-spectrodensitometric method was developed by separation of SCG and FLU on silica gel 60 F254 using chloroform:methanol:toluene:triethylamine in the ratio of (5:2:4:1v/v/v/v) as developing system, followed by spectrodensitometric measurement of the bands at 241nm. The linearity ranges and the mean percentage recoveries/RSD were found to be (0.4-4.4?g/band), 100.24/1.44 and (0.2-1.6?g/band), 99.95/1.50 for SCG and FLU, respectively. A comparative study was conducted between the proposed methods to discuss the advantage of each method. The suggested methods were validated in compliance with the ICH guidelines and were successfully applied for the determination of SCG and FLU in their laboratory prepared mixtures and commercial ophthalmic solution in the presence of benzalkonium chloride as a preservative. These methods could be an alternative to different HPLC techniques in quality control laboratories lacking the required facilities for those expensive techniques. 2012.EnglishAbsorption factorAbsorptivity factorFluorometholoneMean centeringSodium cromoglicateTLC- spectrodensitometricbenzalkonium chloridecromoglycate disodiumeye dropsfluorometholonesilica gelaccuracyarticledensitometrydrug determinationintermethod comparisonspectrodensitometryspectrometryspectrophotometrythin layer chromatographyA comparative study of validated spectrophotometric and TLC- spectrodensitometric methods for the determination of sodium cromoglicate and fluorometholone in ophthalmic solutionArticlehttps://doi.org/10.1016/j.jsps.2012.11.001PubMed ID :