Stability-indicating

The objective of this work was to develop a simple, sensitive, accurate, precise and reproducible high performance liquid chromatography (HPLC) method for the determination of salicylic acid in pharmaceutical dosage forms. Shimadzo Prominance model L20 AD HPLC system equipped with SPD 20A UV-Vis detector was used for the analysis. The separation was done on RESTEX allure C18 column (3 μm, 15 cm × 4.6 mm), for an isocratic elution a mixture of water, methanol and glacial acetic acid (65:35:1, v/v) mobile phase at a wavelength of 254 nm. The flow rate was 1.0mL/min. The RP-HPLC method developed for analysis of salicylic acid was validated with respect to specificity, selectivity, linearity, accuracy, precision and robustness as per the ICH guidelines. The retention time of salicylic acid was 7.575 min. The linearity was established over the concentration ranges of 50-350 μg/mL with correlation coefficients ( r2) 0.999.  The percentage accuracy of salicylic acid ranged from 99.76 -101.66%. The relative standard deviation values for intra-day and inter-day precision was lower than 2.0% and the assay result was found to be in the range 99.57-101.32%. Salicylic acid was subjected to stress conditions such as neutral, acidic, alkaline, oxidation and photolysis degradations as per ICH guidelines. The degradation studies revealed that the drug was found to degrade maximum (1.67%) in alkaline degradation conditions and was highly resistant towards neutral, acidic, oxidative and photolytic degradation conditions.

A new, simple, specific, accurate and precise RP-HPLC method was developed for determination of Baclofen. In the present study, stress testing of Baclofen was carried out according to ICH guidelines Q1A (R2). Baclofen was subjected to stress conditions of hydrolysis, oxidation, photolysis and neutral decomposition. Extensive degradation was found to occur in acidic, condition. Mild degradation was observed in basic and at thermal conditions. Successful separation of drug from degradation products formed under stress conditions was achieved on a Hypersil BDS C18 column (250 mm × 4.6 mm, 5.0 μ particle size) using acetonitrile: acetate buffer (pH 3.7 ± 0.05) (50:50 v/v), at a flow rate of 1.0 mL/min and column was maintained at 40˚C. Quantification and linearity was achieved at 272 nm over the concentration range of 5 - 100 μg/mL for Baclofen. The method was validated for specificity, linearity, accuracy, precision, LOD, LOQ and robustness.