Development and validation of a stability-indicating RP-HPLC method for simultaneous assay of betamethasone dipropionate, chlorocresol, and for the estimation of betamethasone dipropionate related compounds in a pharmaceutical cream and ointment.
A new stability-indicating reversed-phase HPLC (RP-HPLC) method has been developed and validated for simultaneous assay of betamethasone dipropionate (BD) and chlorocresol and also for the estimation of BD related compounds in a pharmaceutical cream matrix. In addition, this newly developed RP-HPLC method was also demonstrated as suitable for a pharmaceutical ointment product that does not contain chlorocresol. The RP-HPLC method uses a Waters SymmetryShield RP18 analytical column (150 × 4.6 mm). Water (mobile phase A) and acetonitrile (mobile phase B) were used in the gradient elution with a flow rate of 1.5 mL/min and detection wavelength at 240 nm. A Waters XBridge Shield RP18 analytical column (150 × 4.6 mm) was identified as an alternate column. The limit of detection (LOD) and the limit of quantitation (LOQ) are 0.02 μg/mL and 0.05 μg/mL, respectively. The precision of the method for BD is less than 0.3% RSD, and the accuracy of BD ranged from 99.5% to 102.6%. The stability-indicating capability of this method has been demonstrated by analyzing aged samples of the product. This RP-HPLC method was successfully validated per ICH guidelines and proved to be suitable for routine quality control use.
Johnston
Stephen E
SE
Analytical Chemistry in Development & Supply-Supply Analytical Sciences (ACDS-SAS), Merck & Co., Inc., Union, NJ 07083, USA.
Gill
Nicole L
NL
Wei
Yu-Chien
YC
Markovich
Robert
R
Rustum
Abu M
AM
D001623:Betamethasone / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D056148:Chromatography, Reverse-Phase / Q000379:methods*; D003408:Cresols / Q000032:analysis* / Q000737:chemistry; D004355:Drug Stability; D016014:Linear Models; D009824:Ointments / Q000737:chemistry; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D003408:Cresols; D009824:Ointments; C006984:chlorocresol; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone