A sensitive, selective, precise, and stability-indicating HPTLC method for quantitative analysis of quetiapine fumarate both as the bulk drug and in formulations has been established and validated. The stationary phase was silica gel and the mobile phase toluene-methanol 8:2 (v/v). This system gave compact bands for quetiapine fumarate (R F 0.37 ± 0.02) . Densitometric analysis of quetiapine fumarate was performed in absorbance mode at 254 nm. There was no chromatographic interference from tablet excipients. Quetiapine fumarate was subjected to acid and alkaline hydrolysis, oxidation, and photodegradation. The drug is susceptible to all these treatments. The degradation products were well resolved from the pure drug with substantially different R F values. The method was validated for linearity, precision, accuracy, selectivity, and specificity in accordance with ICH guidelines. Because the method can effectively separate the drug from its degradation products, it can be used as a stability indicating method.
A simple and sensitive, HPTLC method has been developed for the quantitative estimation of felodipine in it’s single component tablet formulation. The separation was carried out on Merck aluminium plates precoated with silica Gel 60 F254 using n -hexane: ethyl acetate in the ratio of 6:4 (v/v) as mobile phase. Felodipine showed Rf value of 0.53 ± 0.027 and was scanned at 366 nm using Camag TLC Scanner 3. The linear regression data for the calibration plot showed a good relationship with r=0.9792. The method was validated for precision and recovery. The limits of detection and quantification were 23.54 and 71.33 ng/spot respectively. The developed method was successfully used for the assay of felodipine tablet formulations. The method is simple, sensitive and precise; it can be used for the routine quality control testing of marketed formulations.
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