Current Issue : April-June Volume : 2019 Issue Number : 2 Articles : 5 Articles
The stability study is one of the very important parameter for pharmaceutical products. Stability studies are performed at various stages of drug development process to assure efficacy of drug. Stability is an essential factor of quality, safety and efficacy of a drug product. The objective of stability study is to determine the estimation of shelf life, the time period of storage at a specified condition within which the drug product still meets its established specifications. Present article provides an overview of types of stability testing, its application in pharmacy and regulatory guidelines. Stability testing is basically done to achieve a safer quality of drug product. Forced degradation studies (stress testing) are very important tool in pharmaceutical research and development to predict long-term stability. Stress studies should be performed in method development to understand drug behavior but also can be performed with method validation for regulatory filling predict stability and measure impurities....
The article describes a simple, sensitive, rapid, accurate and precise spectrophotometric method for the determination of gliclazide in bulk and pharmaceutical dosage forms by utilizing area under curve (AUC) method. The new method is area under curve method for the analysis of gliclazide using methanol as solvent for the drug. Gliclazide has absorbance maxima at 228.20 nm at area under curve wavelength range of 217.40-236.80 nm. Gliclazide obeys Beer’s law in concentration range 2-10 µg/ml. The limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.31 µg/ml and 0.92 µg/ml respectively. The percentage recovery of the drug for the proposed method ranged from 98.72-100.5% indicating no interference of the tablet excipients. The method developed was validated for linearity, precision, accuracy, LOD, LOQ as per ICH guidelines. The result demonstrates that proposed method is accurate, precise and reproducible while being simple and rapid too for the determination of gliclazide in tablet dosage form....
Chromatographic studies were carried out on aqueous stem extract of Ventilago maderspatana Gaertn belonging to the family Rhamnaceae. It is an important and well known plant in the Indian system of medicine. Stem samples of V. maderspatana was subjected to maceration by using distilled water and ethanol. Aqueous extract was prepared from the stem, of Ventilago maderspatana. Preliminary phytochemical analysis was carried for the extract. Extract was found to contain different phytoconstituents such as alkaloids, glycosides, steroids and sterols, saponins, Flavonoids, carbohydrates and tri- terpenoids and showed the absence of amino acids, proteins and acidic compounds. Fractions were prepared according to polarity and subjected to TLC and HPTLC analysis....
Chromatographic studies were carried out on ethanolic leaves extract of Ventilago maderspatana Gaertn belonging to the family Rhamnaceae. It is an important and well known plant in the Indian system of medicine. Leaf samples of V. maderspatana were subjected to maceration by using distilled water and ethanol. Ethanolic extract was prepared from the leaf, of Ventilago maderspatana. Preliminary phytochemical analysis was carried for the extract. Extract was found to contain different phytoconstituents such as alkaloids, glycosides, steroids and sterols, saponins, Flavonoids, carbohydrates and tri- terpenoids and showed the absence of amino acids, proteins and acidic compounds. Fractions were prepared according to polarity and subjected to TLC and HPTLC analysis....
The current work was carried out for estimation of disulfiram in bulk and pharmaceutical dosage form by utilizing area under curve (AUC) method. For this purpose the wavelength range 204-230 nm was selected. Methanol was used as a solvent throughout the work. Linearity was observed in concentration range 5-25 µg/ml (r2 = 0.99) for the method. Recovery studies for area under curve were found to be 99.32%. The method developed was validated for linearity, precision, accuracy, LOD, and LOQ as per ICH guidelines. The present method was found to be simple, linear, precise, accurate and sensitive which can be used for routine quality control analysis for spectrophotometric estimation of disulfiram in bulk and dosage form....
Loading....