Development and validation of a stability-indicating HPLC method for simultaneous determination of salicylic acid, betamethasone dipropionate and their related compounds in Diprosalic Lotion.
Diprosalic Lotion is an anti-inflammatory drug product that contains salicylic acid and betamethasone dipropionate as active pharmaceutical ingredients (APIs). A reversed-phase high performance liquid chromatography (RP-HPLC) method was developed for simultaneous determination of salicylic acid, betamethasone dipropionate, and their related compounds in Diprosalic Lotion. A 150 mm x 4.6 mm I.D. YMC J'sphere ODS-H80 column at 35 degrees C and UV detection at 240 nm was used. A gradient elution was employed using 0.05% (v/v) methanesulfonic acid solution and acetonitrile as mobile phases. A total of thirty three compounds from Diprosalic Lotion samples were separated in 38 min. The stability-indicating capability of this method has been demonstrated by the adequate separation of all the impurities and degradation products in expired stability samples of Diprosalic Lotion. The method was validated as per the current ICH guidelines.
Shou
Minshan
M
Global Quality Services-Analytical Sciences, Schering-Plough Corporation, Union, NJ 07083, USA. minshan.shou@spcorp.com
Galinada
Wilmer A
WA
Wei
Yu-Chien
YC
Tang
Qinglin
Q
Markovich
Robert J
RJ
Rustum
Abu M
AM
D000893:Anti-Inflammatory Agents / Q000032:analysis; D001623:Betamethasone / Q000031:analogs & derivatives* / Q000032:analysis; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004338:Drug Combinations; D004355:Drug Stability; D020156:Salicylic Acid / Q000032:analysis*
D000893:Anti-Inflammatory Agents; D004338:Drug Combinations; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D020156:Salicylic Acid