R.Tejaswi

Asthma is a complex, chronic inflammatory disease of the lower airways characterized by variable airflow obstruction and airway hyper-responsiveness. Inflammation has a central role in pathophysiology of asthma. Airway inflammation involves an interaction of many cell types and multiple mediators with the airways that eventually results in the characteristic pathophysiological features of the disease. Patients typically present with intermittent symptoms of cough, wheeze, dyspnea, and/or chest discomfort. Asthma is often associated with a history of atopy, and this association in asymptomatic patient is one of the most strongest predictors of asthma.

A simple, accurate, precise and rapid reversed-phase high performance liquid chromatographic (RP-HPLC) method has been developed and subsequently validated for the estimation of Liraglutide in bulk and Parenteral Dosage form. The proposed method is based on the separation of drugs in reversed-phase mode using Waters HPLC 22695 model, Inertsil ODS column (250 x 4.6 mm, 5µm particle size).The optimum mobile phase consisted of methanol: phosphate buffer in the ratio of 85:15 v/v(Phosphate buffer pH 5.5) was selected as a mobile phase, flow rate of 1.0 ml/min and UV detection was set at 246 nm. The retention time was 3.25.The method was validated according to ICH guidelines. It was found to be accurate and reproducible. Linearity was obtained in the concentration range of 20-80 μg/ml . The percentage RSD for precision and accuracy of the method was found to be less than 2%. The proposed method can be successfully applied in the quality control of bulk and pharmaceutical dosage forms.

A Simple, selective, accurate, precise and linear RP-HPLC method was developed and subsequently validated for estimation of cinacalcet in bulk & tablet dosage form. Gradient elution at a flow rate of 0.8ml/min was used for separation of drugs in reversed-phase mode using Waters HPLC 22695 model on a INERTSIL ODS C18 column (150 x 4.6 mm; 5µ) at a ambient temperature. Mobile phase consisted of water: methanol: acetonitrile (20:60:20). The UV detection wavelength was 235nm 20 µl was injected. The retention time for cinacalcet was 3.7min. The percentage RSD for precision and accuracy of the method was found to be less than 2%. The % recovery was within the range between 99.73% and 99.85%. The method was validated as per the ICH guidelines. Key words: cinacalcet, RP-HPLC, validation