In the present investigation, mixed-solvency approach has been applied for the enhancement of aqueous solubility of a poorly water- soluble drug, zaltoprofen (selected as a model drug), by making blends (keeping total concentrations 40% w/v, constant) of selected water-soluble substances from among the hydrotropes (urea, sodium benzoate, sodium citrate, nicotinamide); water-soluble solids (PEG-4000, PEG-6000); and co-solvents (propylene glycol, glycerine, PEG-200, PEG-400, PEG-600). Aqueous solubility of drug in case of selected blends (12 blends) ranged from 9.091 ± 0.011 mg/ml–43.055 ± 0.14 mg/ml (as compared to the solubility in distilled water 0.072 ± 0.012 mg/ml). The enhancement in the solubility of drug in a mixed solvent containing 10% sodium citrate, 5% sodium benzoate and 25 % S cosolvent (25% S cosolvent contains PEG200, PEG 400, PEG600, Glycerine and Propylene glycol) was more than 600 fold. This proved a synergistic enhancement in solubility of a poorly water-soluble drug due to mixed cosolvent effect. Each solubilized product was characterized by ultraviolet and infrared techniques. Various properties of solution such as pH, viscosity, specific gravity and surface tension were studied. The developed formulation was studied for physical and chemical stability. This mixed solvency shall prove definitely a boon for pharmaceutical industries for the development of dosage form of poorly water soluble drugs.
Trainee self-evaluations of key aspects of clinical psychiatry improved significantly after the workshop. The development process described here for implementing a service-based initiative in psychiatry trainee education tailored to local needs may be transferable to other services.
Quantitative spectrophotometric analysis of poorly water-soluble drugs involves use of various organic solvents. Major drawbacks of organic solvents include high cost, volatility and toxicity. Safety of analyzer is affected by toxicity of the solvent used. In the present investigation the use of organic solvent has been avoided, making the method environmentally friendly. Urea has demonstrated enhancement in aqueous solubilities of a large number of poorly water-soluble drugs, thereby widely used as a hydrotropic agent. There was more than 10-fold enhancement in the solubility of ornidazole in 10 M urea solution as compared to its solubility in distilled water. In the present investigation, hydrotropic solution of urea (10 M) was employed as solubilizing agent to solubilize the poorly water-soluble drug, ornidazole, from fine powder of its tablet dosage form for spectrophotometric determination in ultraviolet region at 319 nm. Beer's law was obeyed in the concentration range of 5-25 μg/ml in presence of urea. Presence of urea did not interfere in the analysis. Proposed method is new, rapid, simple, accurate, and reproducible. Statistical data proved the accuracy, reproducibility and the precision of the proposed method.
Objective: Commonly used organic solvents for spectrophotometric analysis of water-insoluble drugs are methanol, ethanol, chloroform, benzene, toluene etc. The main drawbacks of organic solvents include high cost, toxicity, and pollution. Organic solvents have numerous adverse effects caused by single exposure like dermatitis, headache, drowsiness, nausea, eye irritation and long-term exposure causes serious effects such as neurological disorder, chronic renal failure, and liver damage. They should be replaced by other eco-friendly alternative sources.
Methods:The present study is an attempt to show that solid can also be used to act as solvent precluding the use of organic solvents. A simple, safe and sensitive method of spectrophotometric determination of diazepam obeyed beers law in the concentration range of 5-25 mcg/ml at 306 nm.
Results:The results of analyses have been validated statistically for Linearity, accuracy, precision, LOD and LOQ. The results of validation parameters also indicated that proposed method was found to be accurate, precise, reproducible, sensitive, and suitable for routine quality control analysis for estimation of diazepam in bulk drug and solid dosage formulation.
Conclusion:A rapid, simple, and non-toxic UV spectrophotometric method has been developed for the determination and quantification of diazepam. The present method also validated as per ICH guidelines for linearity, precision, accuracy.
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