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Stability indicating HPLC method for the determination of tetrazepam in presence of its acidic degradation products

W.Zarad, S.Emara, R.I.El-Bagary

High performance liquid chromatographic technique was proposed for the determination of tetrazepam (TP) in presence of its degradation products. The method was based on HPLC separation of TP from its acidic degradation products using ZORBAX Eclipse XDB-C18 column at ambient temperature with mobile phase consisting of acetonitrile : distilled water, pH was adjusted to 4.00 using phosphoric acid (50:50 v/v). Quantification was achieved with UV detection at 228 nm based on peak area. The drug was subjected to acid hydrolysis. Complete separation was achieved for the parent compound and all degradation products in an overall analytical run time of approximately 10 min with the parent compound TP eluting at approximately 4.31 min. The method was linear over the concentration range of 1–10 µg/ml (r2 = 1.0000)with a limit of detection and quantitation 0.0349 and 0.1164 µg/ml, respectively. The method has the requisite accuracy, selectivity, sensitivity and precision to assay TP in tablets.