Development and validation of stability-indicating HPTLC method for determination of Rutoside in bulk drug and pharmaceutical dosage form

摘要

A simple, selective, precise and stability-indicating high-performance thin layer chromatography (HPTLC) method for the analysis of Rutoside both in bulk drug and pharmaceutical formulation has been developed and validated. The method employed HPTLC aluminium plates precoated with silica gel 60 F_(254) as the stationary phase. The solvent system consisted of Toluene : methanol: gacial acetic acid(4:1.5:0.5 v/v/v). The system was found to give compact spot for Rutoside (R_f value of 0.40 ± 0.02). Densitometric analysis of Rutoside was carried out in the absorbance mode at 366 ran. The linear regression analysis data for the calibration plots showed good linear relationship with r~2 = 0.999 ± 0.0015 with respect to peak area in the concentration range 700-1200 ng per spot. The mean values ± SD of slope and intercept were 5.2599 ± 1.47 and 2899.5 ± 1.78, respectively, with respect to peak area. The method was validated for precision, recovery and robustness. The limits of detection and quantification were 27.99 and 84.83 ng per spot, respectively. Rutoside was subjected to acid and alkali hydrolysis, oxidation, light and thermal degradation. The drug undergoes degradation under acidic, basic and light exposure conditions. This indicates that the drug is susceptible to acid, base and light (Photo degradation). The degraded product was well resolved from the pure drug with significantly different R_f value. Statistical analysis proves that the method is repeatable, selective and accurate for the estimation of investigated drug. The proposed developed HPTLC method can be applied for the identification and quantitative determination of Rutoside in bulk drug and pharmaceutical formulation.