Salem H.Hassan N.Y.Lotfy H.M.Saleh S.S.Department of Analytical ChemistryFaculty of PharmacyDeraya UniversityMiniaEgypt; Department of Analytical ChemistryFaculty of PharmacyCairo UniversityKasr-El Aini StreetCairo11562Egypt; Department of Pharmaceutical ChemistryFaculty of Pharmaceutical Sciences and Pharmaceutical IndustriesFuture University in EgyptCairo12311Egypt; Department of Analytical ChemistryFaculty of PharmacyOctober University for Modern Sciences and Arts (MSA)October City11787 6thEgypt2020-01-092020-01-0920159334173https://doi.org/10.1556/1006.2015.28.6.3PubMed ID :https://t.ly/6x32lScopusThis work presents a comparative study on the development and validation of two analytical techniques applied for the simultaneous determination of hydrocortisone acetate (HCA), fusidic acid (FSA), methyl paraben (MPB), and propyl paraben (PPB) formulated as a topical cream. The first technique was thin-layer chromatography (TLC)-densitometric method, which was developed by separating the four components on silica gel 60 F254 using methylene chloride-methanol-benzene in the ratio of 10:2:5, v/v, as the developing system, followed by densitometric measurement of the bands at 240 nm. The second technique was the chemometric method using two models: principle component regression model (PCR) and partial least squares (PLS). The suggested techniques were validated in compliance with the International Conference on Harmonization (ICH) guidelines and were successfully applied for the determination of the quaternary mixtures as prepared synthetically in laboratory and in the commercial topical pharmaceutical formulation. Akadmiai Kiad, Budapest.EnglishFusidic acidHydrocortisoneParabensPartial least squaresThin-layer chromatography-densitometryCapillary flowCortisolDichloromethaneDrug productsLeast squares approximationsMixturesParabensPropylparabenRegression analysisSilica gelThin layer chromatographyDensitometric measurementDensitometric methodFusidic acidInternational conference on harmonizationsPartial least square (PLS)Pharmaceutical formulationPrinciple component regressionSimultaneous determinationsChromatographyfusidic acidhydrocortisone acetatemethyl parabenpropyl parabenskin creamanalytic methodArticlechemometricsdensitometrydrug determinationdrug formulationintermethod comparisonpartial least squares regressionprincipal component analysisprocess designprocess optimizationspectrophotometrythin layer chromatographyvalidation studyArticlehttps://doi.org/10.1556/1006.2015.28.6.3PubMed ID :