Force degradation

To develop and validate simple, rapid, linear, accurate, precise and economical reverse phase-high-performance liquid chromatography (RP-HPLC) method for of stress degradation study of Teneligliptin. The separation and quantization were achieved on Inertsil C18(250 mm × 4.6ID,5 um ). The mobile phase selected was Methanol: Water (90:10) at a flow rate of 0.8 ml/min and detection of analytes was carried out at 248nm at pH 3. The method exhibited good linearity over the range of 10–50 µg/mL. The drug is freely soluble in organic solvents Methanol. The drug was identified in terms of solubility studies and on the basis of melting point done by capillary tube method. The drug which when subjected to thermal, photolytic, oxidative, and acidic stress degraded into many degradation products. In most of the cases, the degradation rate was seen to be directly proportional to the amount of stress applied. The thermal stress was increased by increasing the incubation temperature, the faster the degradation took place. The values of LOD were found to be  0.956  ug/ml for TNG  and the calculated LOQ values were found to be 0.171 ug/ml.

Analysis of pharmaceutical and neutral compound and newer drugs commonly used in all the stages of drug discovery and development process. High performance thin layer chromatography (HPTLC) is one of the easiest instrumental technique based on the full capabilities of thin layer chromatography.it is still increasingly finding its way in pharmaceutical analysis with the advancements in the stationary phase and the introduction of the densitometers as detection equipment and the technique achieves high precision and trueness comparable to high performance liquid chromatography (HPLC).

The study describes the simple, sensitive, accurate, rapid and reliable ultra violet spectroscopic method has been developed for determination of Deferiprone in bulk drug and pharmaceutical formulation. Deferiprone is use as second line agent for thalassemia when iron overload from blood transfusion occurs.in order to investigate the stability of drug, a stress testing of drug sample by exposing it to variety of force degradation conditions has been recommended. Deferiprone was subjected to stress degradation under different condition recommended by international conference on harmonization (ICH). Deferiprone shows maximum absorbance at 279nm & calibration graph linear in the concentration range 5-25 Mcg/ml with correlation co-efficient 0.9997.The higher percentage of recovery study indicates that there is no interference of excipients in the presence of formulation. The stability study indicates appreciable changes were observed by treating the drug with acidic hydrolysis, basic hydrolysis and oxidation. However, there is no appreciable changes were observed for thermal stress and photolytic degradation.