Development and validation of reversed phase high performance liquid chromatography method for determination of dexpanthenol in pharmaceutical formulations.
This paper describes the validation of an isocratic HPLC method for the assay of dexpanthenol in aerosol and gel. The method employs the Vydac Proteins C4 column with a mobile phase of aqueous solution of trifluoroacetic acid and UV detection at 206 nm. A linear response (r>0.9999) was observed in the range of 13.0-130 microg mL(-1). The method shows good recoveries and intra and inter-day relative standard deviations were less than 1.0%. Validation parameters as specificity, accuracy and robustness were also determined. The method can be used for dexpanthenol assay of panthenol aerosol and gel with dexpanthenol as the method separates dexpanthenol from aerosol or gel excipients.
Kulikov
A U
AU
Laboratory of Pharmacopoeial Analysis, Scientific and Expert Pharmacopoeial Centre, Astronomicheskaya Street 33, 61085 Kharkov, Ukraine. kulikov@phukr.kharkov.ua
Zinchenko
A A
AA
D000336:Aerosols; D002138:Calibration; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D005782:Gels; D007202:Indicators and Reagents; D010205:Pantothenic Acid / Q000031:analogs & derivatives* / Q000032:analysis; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet; D014269:Trifluoroacetic Acid
D000336:Aerosols; D005782:Gels; D007202:Indicators and Reagents; D012996:Solutions; D010205:Pantothenic Acid; C007288:dexpanthenol; D014269:Trifluoroacetic Acid