A simple, rapid, precise, sensitive, specific and accurate instrumental planar chromatographic method for quantification of fluphenazine hydrochloride in injections has been developed and validated. Chromatographic separation was on precoated silica gel F
HPTLC plates. The mobile phase was methanol-purified water 9:1 (
). Densitometric analysis was performed at 306 nm. The calibration plots were linear in the range 100 to 500 ng μL
with a correlation coefficient of 0.998. The limits of detection (LOD) and quantification (LOQ) were 1.45 and 4.40 ng, respectively. Intra-assay and inter-assay precision, expressed as relative standard deviation (RSD), were in the range 0.73–1.77% (
= 3) and 1.18–1.86% (
= 9), respectively. Recovery of fluphenazine hydrochloride was between 98.29 and 101.53%, with RSD no higher than 1.87%. The method was selective for fluphenazine hydrochloride and the preservatives in the injections. Drug content was within the prescribed limits (95–110% of the labeled content of the formulations) when the method was used to quantify fluphenazine hydrochloride in real pharmaceutical samples. Because the method is sensitive, precise, accurate, and selective for the compound tested, it can be used for routine quality control testing of fluphenazine hydrochloride in injections.
J. Delgado, W. Remers
, Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry, Lippincott-Raven, Philadelphia, 1998.
Remers W., '', in Wilson and Gisvold’s Textbook of Organic Medicinal and Pharmaceutical Chemistry, (1998) -.
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