ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF IMATINIB MESYLATE AND ITS DIMER IMPURITY IN PHARMACEUTICAL FORMULATION BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

 Objective: The present study is to develop a simple, specific, and validated reverse-phase high-performance liquid chromatography (HPLC) method for the determination of imatinib mesylate and its dimer impurity in pharmaceutical dosage form.Methods: A HPLC instrument incorporated with column HiQ Sil C18 (250 mm × 4.6 mm, 5 μm), mobile phase as methanol and acetate buffer pH 3.5 in the ratio of 80:20 v/v was used for the determination of the imatinib mesylate and its dimer impurity. The detection wavelength was set at 273 nm. The flow rate of the mobile phase was 1.0 mL/min.Results: The retention time for imatinib mesylate was 8.060, and for dimer impurity, it was 11.398. The calibration plot was linear (R2=0.9971) and the % mean recoveries for imatinib mesylate were in the range of 99.83–101.57, and for dimer impurity, it was in the range of 98.16–99.18. The limit of detection concentration was found to be 0.570 μg/ml for imatinib mesylate and 0.033 μg/ml dimer impurity and limit of quantification concentration was 1.728 μg/ml for imatinib mesylate and 0.099 μg/ml dimer impurity.Conclusion: The projected method was validated and successfully functional for the estimation of imatinib mesylate and dimer impurity in formulations. It can be adopted apparently for routine quality control and research tests

Engineering cocrystals of Paliperidone with enhanced solubility and dissolution characteristics

In the present study, co-crystals (CCs) of Paliperidone (PPD) with coformers like benzoic acid (BA) and P-amino benzoic acid (PABA) were synthesized and characterized to improve the physicochemical properties and dissolution rate. CCs were prepared by the solvent evaporation (SE) technique and were compared with the products formed by neat grinding (NG) and liquid assisted grinding (LAG) in their enhancement of solubility. The formation of CCs was confirmed by the IR spectroscopy, powder X-ray diffraction and thermal analysis methods. The saturation solubility studies indicate that the aqueous solubility of PPD-BA and PPD-PABA CCs was significantly improved to 1.343±0.162mg/ml and 1.964±0.452mg/ml, respectively, in comparison with the PPD solubility of 0.473mg/ml. This increase in solubility is 2.83-and 3.09-fold, respectively. PPD exhibited a poor dissolution of 37.8% in 60min, while the dissolution of the CCs improved tremendously to 96.07% and 89.65% in 60min. CCs of PPD with BA and PABA present a novel approach to overcome the solubility challenges of poorly water-soluble drug PPD.</jats:p

In-vivo study of quetiapine fumarate superporous hydrogels

This study aims to design and evaluate a gastroretentive drug delivery system using second generation Superporous hydrogels using Factorial design approach. Optimized formulation was assessed for pharmacokinetic parameters by In-vivo study. Pharmacokinetic analysis of Quetiapine Fumarate plasma concentration–time data provided the following pharmacokinetic parameters like Cmax values ranging (690.58 ± 1.1 ng/mL to 524.37 ± 1.6 ng/mL), Tmax values ranging (1.5 ± 0.0 to 6.0 ± 0.0 Hours), AUC values ranging (5345.67 ± 11.34 h.ng/mL to 5345.67 ± 4.59 h.ng/mL). Results obtained for the formulated product prepared with superporous hydrogel technology shows prolonged release while maintaining Q Value with reduce plasma drug fluctuations in comparison to the Pure drug.</jats:p

In-vivo study of quetiapine fumarate superporous hydrogels

This study aims to design and evaluate a gastroretentive drug delivery system using second generation Superporous hydrogels using Factorial design approach. Optimized formulation was assessed for pharmacokinetic parameters by In-vivo study. Pharmacokinetic analysis of Quetiapine Fumarate plasma concentration–time data provided the following pharmacokinetic parameters like Cmax values ranging (690.58 ± 1.1 ng/mL to 524.37 ± 1.6 ng/mL), Tmax values ranging (1.5 ± 0.0 to 6.0 ± 0.0 Hours), AUC values ranging (5345.67 ± 11.34 h.ng/mL to 5345.67 ± 4.59 h.ng/mL). Results obtained for the formulated product prepared with superporous hydrogel technology shows prolonged release while maintaining Q Value with reduce plasma drug fluctuations in comparison to the Pure drug

ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF IMATINIB MESYLATE AND ITS DIMER IMPURITY IN PHARMACEUTICAL FORMULATION BY REVERSE-PHASE HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY

 Objective: The present study is to develop a simple, specific, and validated reverse-phase high-performance liquid chromatography (HPLC) method for the determination of imatinib mesylate and its dimer impurity in pharmaceutical dosage form.Methods: A HPLC instrument incorporated with column HiQ Sil C18 (250 mm × 4.6 mm, 5 μm), mobile phase as methanol and acetate buffer pH 3.5 in the ratio of 80:20 v/v was used for the determination of the imatinib mesylate and its dimer impurity. The detection wavelength was set at 273 nm. The flow rate of the mobile phase was 1.0 mL/min.Results: The retention time for imatinib mesylate was 8.060, and for dimer impurity, it was 11.398. The calibration plot was linear (R2=0.9971) and the % mean recoveries for imatinib mesylate were in the range of 99.83–101.57, and for dimer impurity, it was in the range of 98.16–99.18. The limit of detection concentration was found to be 0.570 μg/ml for imatinib mesylate and 0.033 μg/ml dimer impurity and limit of quantification concentration was 1.728 μg/ml for imatinib mesylate and 0.099 μg/ml dimer impurity.Conclusion: The projected method was validated and successfully functional for the estimation of imatinib mesylate and dimer impurity in formulations. It can be adopted apparently for routine quality control and research tests

Invivo Pharmacokientic and Pharamacodynamic Studies of Optimized Antihyperlipidemic Drug Loaded Solid Lipid Nanoparticle

The purpose of this research is to increase bioavailability by solid lipid nanoparticle (SLN) carrier for low bioavailable drugs (&lt; 5%) such as Lovastatin. Eight SLN loaded Lovastatin was designed and optimised by variables such as Particle Size (PS in nm) and Zeta Potential (ZP in mV) using a micro emulsification technique. SLN 7 was chosen as the optimised formulation according to the findings obtained and the same was chosen for invivo pharmacokinetic and triton-induced antihyperlipidemic operation. SLN7 confirms an improvement in bioavailability of 3.15 percent by an improvement in AUC compared to conventional dosage type (Altoprev) from the pharmacokinetic invivo results. SLN was also an appropriate career in drug delivery for Lovastatin by enhancing bioavailability and therapeutic response. The stability studies of SLN7 revealed that the evaluation parameters of SLN did not change significantly. It was verified from the data that the drug-loaded SLN was stable under varying temperature and humidity conditions. While compare to 25˚c±2˚c/ 60% RH, SLN are more stable in 4˚c±2˚c  and shows good reproducible reports in Particle Size (nm), Zeta potential (mV), PI and EE% data. Therefore, Solid Lipid Nanoparticle is a viable drug carrier mechanism for low bioavailable Lovastatin to improve their bioavailability through efficiently permeating them.</jats:p