Anas Rasheed

A sensitive and selective RP-HPLC method is described for the determination of stability in Acetaminophen and Tramadol dosage forms. Chromatographic separation was achieved on a C18 column using mobile phase consisting of a mixture of mixed Phosphate buffer pH: 3.4 Acetonitrile (30:70v/v/v), with detection of 236nm and flow rate at 1mL/min. Linearity was observed in the range 100-300 µg /ml for Acetaminophen (r2 =0.994) & 10-30µg /ml for Tramadol (r2 =0.994) for the amount of drugs estimated by the proposed methods was in good agreement with the label claim. No chromatographic interference from tablet excipients was found. The proposed methods were validated. The force degradation of the drugs was assessed by different environmental conditions. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.

This study describes the development and validation for the determination of Prasugrel Hydrochloride in bulk and pharmaceutical dosage form by the first-order derivative UV spectroscopy method. The quantification was achieved by the first-order derivative spectroscopy method at 248 nm over the concentration range of 5-25 μg/ml for estimation of Prasugrel Hcl (r2=0.9993) keeping methanol as solvent in zero order derivatization and same 5-25 μg/ml for estimation of Prasugrel Hcl (r2=0.9981) in methanol upon first order derivatization. Procedure does not require prior separation of components from the sample. LOD values for Prasugrel Hclwas found to be 0.591μg/mL for zero order derivatization and upon first order derivatization 0.165 μg/mL. LOQ values for Prasugrel Hclwas found to be 1.970 μg/mL for zero order derivatization and upon first order derivatization0.55 μg/mL. The results of analysis have been validated statistically and recovery studies carried out in the range 50-150% to confirm the accuracy of the proposed method. The relative standard deviation was found to be