Current Issue : January-March Volume : 2020 Issue Number : 1 Articles : 4 Articles
Chromatographic studies were carried out on ethanolic 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. Ethanolic 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....
Quality by design is the modern approach for quality of pharmaceutical. It serves as a bridge between industry and drug regulatory authorities to move towards a scientific, risk based holistic and protective approach for development of pharmaceutical product. The purpose of this project is to discuss the pharmaceutical quality by design and describe how it can be used to ensure pharmaceutical quality. Some of the quality by design (QbD) elements include defining target product profile (TPP), Target product quality profile (TPQP) and identify critical quality attributed (CQA). On this basis we can design the product formulation and the process to meet the product attributes. QbD is necessary in regulatory requirement and to implement new concepts such as design space, ICH guidelines i.e. Q8 pharmaceutical development, Q9 quality risk management and FDA’s process analytical technology (PAT)....
Two simple UV-Spectrophotometric methods have been developed for the estimation of Prochlorperazine Edisylate (PCE) in tablets and parenteral dosage form by using Zero-order UV-Spectrophotometry absorbance method (Method I) and Zero order UV-Spectrophotometry method using the area under curve technique (Method II). Water was used as a solvent. The L-max of PCE in water was found to be 255 nm. In both methods, PCE obeyed linearity in the concentration range of 03-21 microg/ml with correlation coefficient (r2>0.99). Proposed methods were applied for the estimation of PCE in parenteral and tablet dosage form. Both these methods were validated for accuracy, precision and ruggedness as per ICH guidelines....
A simple stability indicating HPLC method was developed and validated for the estimation of ofloxacin and racecadotril in tablet dosage form. Optimized method was developed using discovery C8 column (250×4.6 mm, 5µ) at 295 nm using a mobile phase composition of acetonitrile and orthophosphate buffer of pH 4.8(55:45 v/v) at a flow rate of 1 ml/min. Injection volume was selected to be 10 µl and run time of 7 minutes as analytes were separated around 2.7 and 3.7 minutes respectively. Analytical method was found linear over a range of 25-150 µg/ml for both ofloxacin and racecadotril. Percentage recovery was found to be 98.55-98.85%. Stability studies for the developed method in different conditions were also performed and method was validated according to ICH guidelines and successfully applied for the estimation of drugs in tablet dosage form....
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