Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Glycopyrrolate and Neostigmine in Bulk and Injection.

A stability indicating RP-HPLC method is suggested for determination of Glycopyrrolate-Neostigmine (GLY/NEO) in bulk drugs and injection formulation. GLY/NEO were eluted from a Chromolith High Resolution RP-18e (100 mm×4.6 mm) with buffer solution (pH 3.0) as mobile phase A and a mixture of HPLC grade acetonitrile and water mixture (90:10) as mobile phase B. The gradient was optimized with a flowrate of 0.5 mL/min and wavelength of 222 nm. A complete analytical method validation was effectively carried out as per ICH Q2 (R1) guidelines. Recovery studies were performed at 50-150% level of working concentrations, and results were in the range of 99-101%. The linearity was detected in the range of LOQ to 200% of the specification limits i.e., 0.5% each for NEO and GLY, 0.01% for NEO Impurity B and 1.0% for rest of the impurities with respect to the test concentration of the respective components. For stability study, various stress conditions such as acid, base, oxidation and thermal as per ICH guidelines were studied. The high recovery and low relative standard deviation confirm the suitability of proposed method that can be employed for the routine analysis in bulk and pharmaceutical formulation.

Chitosan as excellent bio-macromolecule with myriad of anti-activities in biomedical applications - A review.

The aim of the study is to explore the myriad of anti-activities of chitosan - deacylated derivative of chitin in biomedical applications. Chitosan consists of reactive residual amino groups, which can be modified chemically to obtain wide range of derivatives. These derivatives exhibit the controlled physicochemical characteristics, which in turn improve its functional properties. Such derivatives find numerous applications in the field of biomedical science, agriculture, tissue engineering, bone regeneration and environmental science. This study presents a comprehensive overview of the multifarious anti-activities of chitosan and its derivatives in the field of biomedical science including anti-microbial, antioxidant, anti-tumor, anti-HIV, anti-fungal, anti- inflammatory, anti-Alzheimer's, anti-hypertensive and anti-diabetic activity. It briefly details these anti-activities with respect to its mode of action, pharmacological effects and potential applications. It also presents the overview of current research exploring novel derivatives of chitosan and its anti- activities in the recent past. Finally, the review projects the prospective potential of chitosan and its derivatives and expects to encourage the readers to develop new drug delivery systems based on such chitosan derivatives and explore its applications in biomedical science for benefit of mankind.