Application of Stability-Indicating RP-TLC Densitometric Determination of Rabeprazole Sodium in Bulk and Pharmaceutical Formulation

[摘要] A  simple, sensitive, selective, precise and  stability- indicating reversed-phase thin layer chromatography (RP-TLC) densitometric determination of  rabeprazole sodium as bulk and  from pharmaceutical formulation have been developed and validated as per International Conference on Harmonisation (ICH) guidelines. The method employed RP-TLC aluminium plates precoated with silica gel 60 RP-18 F-254 S as the stationary phase. The mobile phase consisted of acetone: water (3.5:1.5 v/v). The system was found to give compact spot for rabeprazole sodium (Rf value of 0.45 ± 0.02). Densitometric detection was carried out at λ = 284 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r = 0.9998 in the working concentration range of  400 – 2400 ng spot -1.  The method was validated for precision, accuracy, ruggedness, robustness, specificity, recovery, limit of detection (LOD) and limit of quantitation (LOQ). The LOD and LOQ were found to be19.89 and 60.29 ng per spot, respectively. The drug was subjected to acid and alkali hydrolysis, oxidation, dry heat and photodegradation, all the peaks of the degradation products were well resolved from the standard drug with significantly different Rf values. Statistical analysis proves that the developed RP- TLC densitometry method is reproducible and selective.  The developed RP-TLC densitometric method can be applied for identification and quantitative determination of rabeprazole sodium in bulk drug and tablet formulation.

[学科分类] 分析化学

[关键词] Rabeprazole sodium; Reverse-phase thin-layer chromatography; Validation; Stability-indicating; Degradation