Abstract
High-performance liquid chromatographic and two chemometrics-assisted UV spectrophotometric methods were proposed for the resolution of pharmaceutical binary mixtures of lidocaine hydrochloride(LH) and fluocortolone pivalate, (FCP) and their ternary mixture with chlorquinaldol (CQ) without any chemical pretreatment. The chromatographic separation was achieved on normal-phase C8 analytical column with a mobile phase consisting of a mixture of phosphate buffer : acetonitrile (40:60, v/v) buffered with 0.5% triethylamine, (adjusted to pH 3.3 ± 0.2 with o- phosphoric acid) with flow rate 1 mL/min. Quantitation was achieved with UV detection at 220 nm. Also, the resolution has been accomplished by using numerical spectrophotometric methods as principal component regression (PCR) and partial least squares (PLS-1) applied to the UV spectra of the mixture. The proposed methods were validated and successfully applied for the analysis of dosage forms and laboratory-prepared mixtures containing the components combination. The developed analytical methods did not show any interference of the excipients when applied to pharmaceutical dosage forms. The results of HPLC were compared with PLS-1 and PCR methods and a good agreement was found.
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