title: Development and Validation of a Stability Indicating RP-HPLC Method for Hydrocortisone Acetate Active Ingredient, Propyl Parahydroxybenzoate and Methyl Parahydroxybenzoate Preservatives, Butylhydroxyanisole Antioxidant, and Their Degradation Products in a Rectal Gel Formulation.
abstract: A stability indicating method was established through a stress study, wherein different methods of degradation (oxidation, hydrolysis, photolysis, and temperature) were studied simultaneously to determine the active ingredient hydrocortisone acetate, preservatives propyl parahydroxybenzoate, and methyl parahydroxybenzoate, antioxidant butylhydroxyanisole (BHA), and their degradation products in a semisolid dosage gel form. The proposed method was suitably validated using a Zorbax SB-Phenyl column and gradient elution. The mobile phase consisted of a mixture of methanol, acetonitrile, and water in different proportions according to a planned program at a flow rate of 1.5 mL/min. The diode array detector was set at 240 nm for the active substance and two preservatives, and 290 nm for BHA. The validation study was conducted according to International Conference on Harmonization guidelines for specificity, linearity, repeatability, precision, and accuracy. The method was used for QC of hydrocortisone acetate gel and for the stability studies with the aim of quantifying the active substance, preservatives, antioxidant, and degradation products. It has proved to be suitable as a fast and reliable method for QC.
authors: University of Barcelona, School of Pharmacy, Pharmacy and Pharmaceutical Technology Department, Unit of Pharmaceutical Technology, Avda Joan XXIII s/n 08028, Barcelona, Spain.
authors: Magda
authors: M
authors: Ascaso
authors: Pilar
authors: P
authors: Pérez-Lozano
authors: Mireia
authors: M
authors: García
authors: Encarna
authors: E
authors: García-Montoya
authors: Montse
authors: M
authors: Miñarro
authors: Josep R
authors: JR
authors: Ticó
authors: Anna
authors: A
authors: Fàbregas
authors: Carolina
authors: C
authors: Carrillo
authors: Rocío
authors: R
authors: Sarrate
authors: Josep M
authors: JM
authors: Suñé-Negre
mesh_terms: D000975:Antioxidants / Q000737:chemistry; D002083:Butylated Hydroxyanisole / Q000737:chemistry*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D005782:Gels / Q000737:chemistry; D006854:Hydrocortisone / Q000031:analogs & derivatives* / Q000737:chemistry; D062385:Hydroxybenzoates / Q000737:chemistry*; D011310:Preservatives, Pharmaceutical / Q000737:chemistry*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D000975:Antioxidants; D005782:Gels; D062385:Hydroxybenzoates; D011310:Preservatives, Pharmaceutical; D002083:Butylated Hydroxyanisole; C021650:hydrocortisone acetate; D006854:Hydrocortisone