Authors:Nitin Kumar, D. Sangeetha, L. Kalyanraman, and K. Sainath
The objective of the current research is to understand the degradation behavior of avanafil under different stress conditions and to develop a stability-indicating high-performance liquid chromatography (HPLC) method for simultaneous determination of degradants observed during degradation. Avanafil tablets were exposed to acid, base, water, oxidative, thermal, and photolytic degradation conditions. In acid, oxidative, thermal, and humidity degradation, significant degradation was observed. All the degradants observed during degradation were separated from known impurities of avanafil by using reverse-phase (RP)-HPLC. Mobile phase A, 0.1% trifluoro acetic acid and triethylamine in water, and mobile phase B, water and acetonitrile in the ratio of 20:80 (v/v), were used at a flow rate of 1.2 mL/min in gradient elution mode. Separation was achieved by using Inertsil ODS 3 column (3 μm, 4.6 mm × 250 mm) at 45 °C. Peak responses were recorded at 245 nm. Method capability for detecting and quantifying the degradants, which can form during stability, was proved by demonstrating the peak purity of avanafil peak in all the stressed samples. Mass balance was established by performing the assay of stressed sample against reference standard. Mass balance was found >97% for all the stress conditions. The developed analytical method was validated as per International Conference on Harmonization (ICH) guidelines. The method was found specific, linear, accurate, precise, rugged, and robust.
Authors:N. Kumar, Nitin Kumar, A. Shukla, S. C. Shankhdhar, and D. Shankhdhar
Global warming is rising as a serious concern affecting agricultural production worldwide. Rice is a staple food crop and the threshold temperature for its pollination is 35 °C. A rise in temperature above this value can cause pollen sterility and may severely affect fertilization. Therefore, a study emphasizing the rise in temperature with respect to pollen viability was conducted with eleven rice genotypes during kharif seasons of 2010 and 2011 in indigenous field conditions. Increasing mean temperature by 12 °C at full flowering was found to severely affect the spikelet attributes of the crop. All genotypes showed spikelet sterility above 90% during both seasons. The study indicated that increased temperature may limit rice yield by affecting spikelet fertility and grain filling. The net reduction in grain yield was 30.4% and 27.6% in 2010 and 2011, respectively. A clear reduction in pollen size under high temperature was shown by scanning electron microscopy.