Thesis (M.Sc.) - Cairo University - Faculty of Pharmacy - Department of Analytical Chemistry

The health and the safety of pharmaceutical products consumers are protected by the national control laboratories. Prior the pharmaceutical product is approved to the market; several tests must be applied to ensure that these products meet the accepted standard of quality, efficacy and safety. However, time consuming method is usually stood as barrier to achieve fast results. Moreover, developing country laboratories are suffering from deficiency of sophisticated analytical instruments. This study concerned with developing fast, simple, inexpensive and accurate accessible analytical methods for the simultaneous determination of selected drugs containing amide group namely gliquidone and vildagliptin. Stability-indicating chromatographic methods were applied to determine gliquidone in presence of its alkaline degradation products using 25 cm, C18 column with limit of detection 0.0.081 æg/ml for HPLC method and 0.094 æg/band for TLC method. Also, Separation of vildagliptin from its impurity L-proline was achieved by HPLC using 25 cm, CN column with limit of detection 0.532 æg/ml and 0.403 æg/band for TLC method. Stability-indicating spectroscopic methods were used to determine gliquidone in presence of its alkaline degradation products by derivative ratio and mean centering ratio spectrophotometric methods with LOD 0.324æg/ml and 0.180æg/ml, respectively. Moreover, normal spectroflouremetric method was achieved to determine gliquidone in raw material and in dosage form with LOD 0.039æg/ml, but this method could not be applied as stability-indicating method due to sever overlapping between the emission spectrum of drug and alkaline degradation products

Issued also as CD