Development and Validation of Stability Indicating RP-HPLC Method

Newly developed and validated reverse phase high performance liquid chromatography (RP-HPLC) method for the quantitative analysis of dexibuprofen. We could also develop and validate stability indicating RP-HPLC methods for dexibuprofen. RP-HPLC method was developed for the determination of dexibuprofen in single dosage forms. Stability indicating RP-HPLC methods were also developed for the determination of dexibuprofen in single dosage forms. Forced degradation study of dexibuprofen was carried out under acidic, alkaline, oxidative, dry heat and photostability conditions. Newly developed stability indicating RP-HPLC method was successfully applied to determine the drugs content from the pharmaceutical dosage forms in presence of their degradation products. This proposed method was validated as per ICH guidelines and can be applied successfully in routine analysis for quantitative analysis of dexibuprofen in single dosage forms without interference from commonly used excipients and additives.