Development and validation of HPLC method for analysis of dexamethasone acetate in microemulsions

被引：22

作者：

Cocenza Urban, Maria Cristina

Mainardes, Rubiana Mara

Daflon Gremiao, Maria Palmira

机构：

[1] Departamento de Fármacos e Medicamentos, Faculdade de Ciências Farmacêuticas de Araraquara, Universidade Estadual PaulistaJúlio de Mesquita Filho

[2] Departamento de Farmácia, Universidade Estadual do Centro-Oeste

来源：

BRAZILIAN JOURNAL OF PHARMACEUTICAL SCIENCES | 2009年 / 45卷 / 01期

关键词：

Analytical method/validation; Dexamethasone acetate/determination; High performance liquid chromatography/quantitative analysis; Microemulsions/quantitative analysis;

D O I：

10.1590/S1984-82502009000100010

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

A simple, rapid, accurate and sensitie method was developed for quantitative analysis of dexamethasone acetate in microemulsions using high performance liquid chromatography (HPLC) with UV detection. The chromatography parameters were stainless steel Lichrospher 100 RP-18 column (250 mm x 4 mm i.d. 55 mu m particle size), at 30 +/- 2 degrees C. The isocratic mobile phase was methanol water (65.35; v/v) at a flow rate of at 1.0 mL.min(-1). The determinations were performed using UV-Vis detector set at 239 nm. Samples were prepared with methanol and the volume injected was 20 mu L. The analytical curve was linear (r(2) 0.9995) over a wide concentration range (2.0-3.0 mu g.mL(-1)). The presence of components of the microemulsion did not interfere in the results of the analysis. The method showed adequate precision, with a relative standard deviation (RSD) smaller than 3%. The accuracy was analyzed by adding a standard drug and good recovery values were obtained for all drug concentrations used. The HPLC method developed in this study showed specificity and selectivity with linearity in the working range and good precision and accuracy, making it very suitable for quantification of dexamethasone in microemulsions. The analytical procedure is reliable and offers advantages in terms of speed and low cost of reagents.

引用

页码：87 / 92

页数：6

共 15 条

[1] BRITTAIN H.G., Validação de métodos analíticos não cromatográficos., Pharm. Tech, 6, pp. 4-9, (1998)
[2] CAPELLA-PEIRo M.E., GIL-AGUSTI M., MONFERRER-PONS L., ESTEVE-ROMERO J., Direct injection micellar liquid chromatographic method for the analysis of corticosteroids in creams, ointments and other pharmaceuticals, Anal. Chim. Acta, 454, pp. 125-135, (2002)
[3] CONSTANTINIDES P.P., SCALART J.P., Formulation and physical characterization of water-in-oil microemulsions containing long- versus medium-chain glycerides, Int. J. Pharm, 158, pp. 57-68, (1997)
[4] FORMARIZ T.P., URBAN M.C.C., SILVA-JR A.A., GREMIAO M.P.D., OLIVEIRA A.G., Microemulsões e fase líquidas cristalinas como sistemas de liberação de fármacos., Revista Brasileira de Ciências Farmacêuticas, 41, pp. 301-312, (2005)
[5] GARCIA C.V., BREIER A.R., STEPPE M., SCHAPOVAL E.E., OPPE T.P., Determination of dexamethasone acetate in cream by HPLC, J. Pharm. Biomed. Anal, 31, pp. 597-600, (2003)
[6] GASCO M.R., GALLARATE M., PATTARINO F., On the release of prednisone from oil in water microemulsions, Farmaco, 43, pp. 325-350, (1988)
[7] GUO D., CHEN N.N., YANG X.X., HOU L.B., Determination of dexamethasone sodium phosphate content in fuyankang cream by high-performance capillary electrophoresis, Di Yi Jun Yi Da Xue Xue Bao, 24, pp. 839-840, (2004)
[8] HASHIGUSHI T., YASUTAKE T., MANAKO T., OTAGIRI M., In vitro percutaneous absorption of prednisolone derivates based on solubility parameter, Int. J. Pharm, 158, pp. 11-18, (1997)
[9] KRZEK J., MASLANKA A., LIPNER P., Identification and quantification of polymyxin B, framycetin, and dexamethasone in an ointment by using thin-layer chromatographic with densitometry, J. AOAC Int, 88, pp. 1549-1554, (2005)
[10] LEHMANN L., KEIPERT S., GLOOR M., Effects of microemulsion on the stratum corneum and hydrocortisone penetration, Eur. J. Pharm. Biopharm, 52, pp. 129-136, (2001)

← 1 2 →