Stability-Indicating RP-TLC/Densitometry Determination of Raloxifene Hydrochloride in Bulk Material and in Tablets

Abstract

A stability-indicating RP-TLC/Densitometry method for analysis of Raloxifene hydrochloride both in bulk material and in tablets was developed and validated. Densitometric analysis of Raloxifene hydrochloride was carried out at 311 nm on TLC aluminium plates precoated with silica gel 60RP-18 F 254 S as the stationary phase and methanol : water : ammonia (95 : 05 : 0.1 v / v ) as mobile phase. Raloxifene hydrochloride was well resolved at R f 0.55 ± 0.02. The linear regression analysis data for the calibration plots showed good linear relationship with r 2 = 0.9969 ± 0.0015 with respect to peak area in the concentration range 100–600 ng per band. The mean value ± SD of slope and intercept was found to be 15.05 ± 0.44 and 201.9 ± 29.58 with respect to peak area. The limits of detection and quantification were 9.27 ng and 27.10 ng, respectively. Raloxifene hydrochloride was subjected to acid and alkali hydrolysis, oxidation, dry heat, and photodegradation. The drug underwent degradation under basic and oxidation conditions. This indicates that the drug is susceptible to alkali hydrolysis and oxidation. The proposed developed RP-TLC/Densitometry method can be applied for identification and quantitative determination of Raloxifene hydrochloride in bulk material and tablets.