The current practice of characterization and control of impurities in pharmaceutical substances and products are reviewed with emphasis on issues specific to the active pharmaceutical ingredient and pharmaceutical formulations. The control of pharmaceutical impurities in the pharmaceutical industry is an important task to the formulator. The International Conference on Harmonization (ICH) has f...

Venous varix occurring with a developmental venous anomaly is a rare disease entity that may be found incidentally by conventional cerebral angiography. Developmental venous anomaly (DVA) without venous varix has a normal physiology, and thus, in most cases treatment is not necessary. Although most varices with venous anomalies are known to be clinically silent but if hemorrhage from increased ...

In this study elements of validation of headspace GC method of determination of residual methanol, n-pentane, ethanol, tert-butylamine, 2propanol, acetonitrile, dichloromethane and toluene in pharmaceutical substance are presented. Validation of the method included: selectivity, system precision, method precision, accuracy (recovery), limits of detection and quantitation (in substance), robustn...

A simple, precise and economical spectrophotometric method has been developed for the estimation of Atazanavir sulfate in bulk and pharmaceutical formulations. The quantitative determination of the drug was carried out using the first order derivative method. Atazanavir sulfate shows a sharp peak at 254.0 nm in first order derivative spectrum with n =1. The drugs follows Beer-Lambert’s law in t...

For determination of aliskiren in commercial samples, an analytical UV spectrophotometric method was developed and validate according to ICH guideline. The method was linear in the range between 40 and 100 μg mL (r = 0.9997, n = 7) and exhibited suitable specificity, accuracy, precision, and robustness. It is simple, it has low cost, and it has low use polluting reagents. Therefore, the propose...

Pramipexole belongs to a class of nonergot dopamine agonist recently approved for the treatment of early and advanced Parkinson's disease. A validated specific stability indicating reversed-phase liquid chromatographic method has been developed for the quantitative determination of pramipexole in bulk as well as in pharmaceutical dosage forms in the presence of degradation products. Forced degr...

The method has been developed and validated for the determination of hydroquinone in liposomal formulation. The samples were dissolved in methanol and evaluated in 293 nm. The validation parameters such as linearity, accuracy, precision, specificity, limit of detection (LOD) and limit of quantitation (LOQ) were determined. The calibration curve was linear in 1-50 µg /mL range of hydroquinone an...