Krupa Chaitanyakumar Thula

Simple, rapid, accurate, precise and economical UV-spectrophotometric methods have been developed and validated for simultaneous estimation of Aspirin and Lansoprazole in a Synthetic mixture. The first method is the Q-Absorption ratio method, which involves formation of Q-absorption equation at 299.2 nm (isoabsorptive point) for Aspirin and Lansoprazole  and also at 276.6 nm (λmax of Aspirin). The Second method is Dual Wavelength Method. The method was based on determination of Aspirin at the absorbance difference between 272.28 nm and 286.41 nm and Lansoprazole at the absorbance difference between 269.20 nm and 294 nm. Developed methods were validated according to ICH Q2 (R1) guidelines. The methods were found to be linear between the range of 33.3-166.6 µg/ml for Aspirin and 5-25µg/ml for Lansoprazole for both methods. The precision (intra-day, inter-day) of methods were found within limits (RSD

Medical devices have been become more important in the health care sector. It is mostly used for diagnosis and prevention of public health. There are more than 8000 generic medical device groups, where some medical devices contain drugs. This increases the demand for better regulatory frameworks to ensure that products entering in the market are safe as well as efficient. One of the major issues for companies developing and producing medical devices is to be updated on the bases of regulatory requirements and to implement them in the process. This is particularly true in developing countries, where assessments of health technology are rare and where little regulatory controls exist to prevent the importation or use of substandard devices. So regulation of medical device is a vital need in Pharmaceutical Sector. This article mainly focuses on classification, classification rules, registration procedure, documents required for registration of medical device and fees for application of medical devices in Australia and India. In Australia medical devices are regulated by Therapeutics Good Administration (TGA) whereas in India medical devices are regulated by Central Drugs Standard Control Organization (CDSCO).