Quantitative X-ray fluorescence analysis: Trace level detection of toxic elemental impurities in drug product by ED-XRF spectrometer.

Inorganic impurity analysis of pharmaceutical drug products is of paramount importance at trace levels due to the availability of toxic metals. The existing techniques require extensive development and chemical treatment to evaluate the presence of class I (Pb, Cd, Hg and As) and class II (Co, V and Ni) heavy metal elements which are harmful to the environment. To overcome these issues, a cost and time effective wavelength dispersive X-ray fluorescence spectrometry (XRF) was introduced to determine the concentration of trace elements in one of the angiotensin receptor blocker (ARB) (tablet sample 300 mg) according to guidelines addressed in ICH Q3D and USP. The validation study focused on class I and class II elements are also in accordance with regulatory guidelines. Overall it includes the comprehensive characterization of analytical method which is compliant with the requirement of USP. The novelty of this work includes the application of EDXRF in routine analysis of trace elements (especially volatile Hg) present in the pharmaceutical product beyond the previously published studies for the limited number of the non-pharmaceutical regime. Apart from this it also requires minimal sample preparation and method development and is able to quantify toxic impurities which are present in the sample in less than 20 ppm concentration, with the lowest level of detection up to 0.1 ppm.

Pro-healing effect of Cinnamomum zeylanicum bark.

The ethanol extract of the bark of Cinnamomum zeylanicum was evaluated for wound healing activity in Wistar rats. The extract was administered by the oral route at a dose of 250 mg/kg and 500 mg/kg body weight (1/8 and 1/4 of LD(50), respectively) for all the wound models selected, excision, incision and dead space wounds. The extract significantly enhanced the wound breaking strength in the case of incision wound, the rate of wound contraction and the period of epithelization in the case of excision wound. The granulation tissue weight, its breaking strength and its hydroxyproline content was also increased by the extract in the dead space wound.