Rajasekaran A*, Preethi N, Arivukkarasu R
Department of Pharmaceutical Analysis, KMCH College of Pharmacy, Coimbatore, India
A simple, sensitive, selective, precise and stability indicating high-performance thin-layer chromatographic method was developed and validated for the determination of raloxifene hydrochloride as per the ICH guidelines. Precoated aluminium plates with silica gel 60F254 as the stationary phase and methanol: water: ammonia solution (9.4:0.5:0.1) was used as mobile phase this solvent system gave compact spot for raloxifene hydrochloride with Rf value of 0.60 ± 0.02 detected at 254 nm. Raloxifene was subjected to acid and alkali hydrolysis, oxidation and photodegradation. Peak area was in the concentration range of 100–500 ng spot−1 with r value as 0.999. The mean value (±SD) of slope and intercept were 9.66 ± 0.05 and 956.33 ± 27.67 respectively. The method was validated for precision, accuracy, ruggedness and recovery. The LOD and LOQ were found to be 40.8 and 132.2 ng spot−1. The peaks of the degradation products were well resolved from the pure drug and had significantly different Rf values. Since the degraded products under acidic, basic and oxidative conditions not interfered in the estimation of `pure drug it can be employed as stability-indicating one.
Key words: Raloxifene, HPTLC, stability indicating, stress degradation, Validation