ICH GUIDELINE PRACTICE: A VALIDATED POLAR IONIC MODE CHIRAL HPLC METHOD DEVELOPMENT AND ITS APPLICATION FOR THE DETERMINATION OF SAXAGLIPTIN STEREOISOMERS IN BULK AND PHARMACEUTICAL FORMULATIONS D Suresh, D Sista, Y Triveni, Ch Lakshmi Prasanna, P Seetharam, A. V Seetharam Rasayan Journal of Chemistry, 2026 SAXAGLIPTIN (SAX) is a commonly used and orally active medicinal ingredient for the therapy ofnon-insulin- dependent diabetes. Three out of all the stereo isomers were generated in minor quantities as impurities duringthesynthesis of SAX, lowering the drug's purity. The primary goal of this work was to investigate several chiral stationary phases (CSPs) in order to identify the phase providing the most efficient and reliable separation of thestereoisomers. Subsequently, chromatographic requirements were adjusted, and the developed technique wascomprehensively confirmed using multiple standard validation parameters. CH3OH:CH3COOH:(C2H5)3N(100:0.1:0.1, v/v/v/) . Compared to Chiralpak-IG, the Chirobiotic V2 column effectively separated the SAXstereoisomers with good resolution in Polar Ionic Mode. The validated chiral HPLC method showed excellent selectivity with resolution >1.95 and tailing factor <1.35 for all analytes. The validated analytical procedureshowed outstanding sensitivity, with limits of detection ranging from 0.32 to 0.68 µg/mL and limits of quantification spanning 1.09 to 2.13 µg/mL for DIA-1, DIA-2, ENA, and SAX. The proposed analytical strategy demonstrated strong selectivity, precision, accuracy, linearity, and robustness for the reliable identificationand quantification of SAX stereoisomers, according to ICH guidelines. The described approach has been usedtodetermine the stereoisomers of SAX bulk pharmaceuticals and pharmaceutical formulations with great success.
The Formation Analysis of Ca (II), Mg (II), Zn (II) and 5-Hydroxysalicylic Acid Binary Complexes in Cetyltrimethylammonium Bromide Cationic Micelles Malla Ramanaiah, Malla Balakrishna, Robbi Neeraja, Sattaru Gouthamsri, Pondala Seetharam Indian Journal of Pharmaceutical Education and Research, 2023 Abstract: Aim: The aim of the present study is to confirm the species formed under the used experimental conditions and to validate the models by statistical treatment of the data. As the results obtained in this study have specific applications in extraction metallurgy, nuclear energy industry, and analytical methods, medical, environmental, and industrial research. These applications all require stability constant values of high reliability and sources of critically evaluated published constants are referenced. Stability constant is useful physical entity, which explains the importance and function of various complexes in biological systems. Background: Despite the availability of information about the effect of organic-water media, anionic-surfactants media on the stability of binary complexes, this data related to 5-Hydroxysalicylic acid with essential metals Ca (II), Mg (II), Zn (II) in cationic-surfactant medium is carried out in this study. Materials and Methods: Aqueous solutions of Ca, Mg Zn and Cetyltrimethylammonium Bromide were prepared using triple-distilled water. The alkali metric titrations were carried out in a medium containing varying compositions of Cetyltrimethylammonium Bromide (CTAB)-water mixtures (0.0-2.5% w/v) used by maintaining an ionic strength of 0.16 mol dm-3 with sodium hydroxide at 303.0+0.1 K. An ELICO (Model L1-120) pH-meter (readability 0.01 pH units) pH meter was used to carry out the pH values. A well-defined computer algorithm known as MINIQUAD75 was used to perform an analysis on the complex species models. On a few different complex species, exhaustive modelling work has been done. Results: The formed metal-ligand complexes in between Ca(II), Mg(II), Zn(II) and Cetyltrimethylammonium bromide are ML2H3, ML2H4, and ML3H4. These complexes have been identified to be the predominant complex species that have formed. On the basis of the statistical parameters, the chemical modelling approach that provides the best fit has been adopted. The complex species were verified through the statistical study of the data. Based on electrostatics, the change in stability of complex species as a function of surfactant composition has been shown, the distribution of chemical species with respect to pH and compositional diversity is also shown explores how possible complicated equilibria. The data acquisition of acid-base equilibria and determination of stability constants were performed using MINIQUAD75 algorithm and the distribution patterns of the complexes with varying pH and compositions of surfactants were presented from the plots of SIM run data. Conclusion: A study of the chemical speciation of ternary complexes of Ca(II), Mg(II), and Zn(II) with 5-HSA in micellar medium reveals the compartmentalization of metabolic reactions. The study gives an insight into the metal availability /metal transport in bio fluids. The binary complexes make the ‘‘metal available’’ in biological systems due to their decreased stability. It is observed that the stability constants are more affected by concentration of alkali than other parameters like concentration of acid, ligand and others. Keywords: Binary complexes, Chemical speciation, Cetyltrimethylammoniumbromide, Stability constants, Anionic surfactant, Cationic micelles, Complexes.
Synthesis of Quinoline Derivatives Using Double Perovskite Bi1.97Eu0.03MoO6 Heterogeneous Nanocatalyst D. Tejeswara Rao, P. Seetharam Russian Journal of Organic Chemistry, 2022 Double perovskite Bi1.97Eu0.03MoO6 was synthesized and used to catalyze the synthesis of quinoline derivatives from aliphatic ketones and 2-aminoaryl ketones at room temperature. The catalyst showed excellent activity and stability, and it could be reused at least six times without significant loss of activity.
Potentiometric Studies on Bioactive Material Species of Ternary Complexes P. Seetharam, M. Balakrishna, B. Sathish Mohan, G. Satyanarayana, B. B. V. Sailaja Russian Journal of General Chemistry, 2020 Complexation of essential metal ions with glycylglycine and histamine in cetyltrimethylammonium bromide (CTAB) has been presented in this study, which targets insight in the distribution of species, effect of surfactants on stability constants of ternary complexes, and effect of concentration of alkali, acids, ligands, and metal ions on the stability constants. The studied complexes are MLXH2, ML2XH2, and MLX2H3. The advanced principles of mathematics and fuzzy logic have been employed to correlate chemical problems, known as chemo metrics. A potentiometer has been used for analysis, and the results obtained have been processed through gran plot method, SCPHD used for best fit chemical model. MINIQUAD75 has been used for refinement of the results.
Surfactant Effect on Acido-Basic Equilibria of Glycylglycine and Histamine in Neutral Micellar Media Research Journal of Chemistry and Environment, 2020
Potentiometric studies of complex equlibria of CaII, MgII and ZnII with 5-sulphosalicylic acid in cationic micelles of CTAB M. Ramanaiah, P. Seetharam, M. Balakrishna, B. Rama Raju Heliyon, 2019 Formation of metal ligand complex species of 5-sulphosalicylic acid with CaII, MgII and ZnII metal ions have been studied potentiometrically in various composition (0.0, 0.5, 1.0. 1.5, 2.0, and 2.5% w/v) of cetyltrimethylammonium bromide (CTAB). The study has been carried out at 303 K temperature and maintaining 0.16 mol dm−3 ionic strength using NaCl. The dynamic species belongs to 5-sulphosalicylic acid are LH2- and LH2-. The best fit of complex speciation has been preferred on basis of statistical parameters like skewness, χ2, Kurtosis and crystallographic R-factor. ML2H, ML2H2 and ML3H3 type complex were formed by the complexation of 5-sulphosalicylic acid with the metal ions. The change in stability of complex species with composition of the surfactant has been illustrated on the basis electrostatic grounds. Distribution of chemical species with respect to pH and various compositions medium and probable complex equilibria are also studied.
Protonation equilibria of glycylglycine and histamine in cationic micellar media Journal of the Indian Chemical Society, 2016
pH-metric investigation on binary complexes of Ca (II), Mg (II) and Zn (II) with glycylglycine in TX100-water mixtures Der Pharma Chemica, 2016
Chemical speciation of ternary complexes of pb11, cd11 and hgn with l-phenylalanine and maleic acid in txloo-water mixtures Journal of the Indian Chemical Society, 2014
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