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A simple, specific, accurate and stability-indicating reversed phase high performance liquid chromatographic (RP-HPLC) method was developed for the estimation of Cabozantinib, using a reversed-phase C18 column (250 mm × 4.6 mm, 5 µm) a mobile phase consisting of 0.1% Formic acid:acetonitrile:methanol (35:33:32 v/v), at a flow rate of 1.0 mL/min and...
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A Stability indicating RP-HPLC assay method has been developed to quantitate Raltegravir potassium in tablet dosage forms. The comprehensive forced stress testing has been carried out as per ICH guideline Q1A (R2). The drug was subjected to hydrolysis (acid, alkali and neutral degradation), humidity, oxidation and thermal decomposition. RP-HPLC met...
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... Another method was devised with a mobile phase of 0.1 percent Formic acid:acetonitrile:methanol (35:33:32 v/v) with a C18 colmn (250 4.6 mm, 5 m). The drug's retention time was discovered to be 6.03 minutes (24). Another approach for estimating cabozantinib and nivolumab was developed utilising a C18 column (150 x 4.6mm, 3.5). ...
Liposomes were created to deliver drugs to specific locations. The development of an analytical approach to determine the medication contained in the liposome is critical. The goal of the research was to create a reverse phase high performance liquid chromatography (RP-HPLC) method for determining cabozantinib concentration. The method was developed using an Agilent zorbax eclipse XDB C18 column (4.6 x 250 mm, 5m) with a mobile phase of methanol:0.1 percent OPA (Ortho phosphoric acid) in an 80:20 percent v/v ratio. The mobile phase flow rate was kept constant at 0.7 ml/min. The detection was done at a wavelength of 244 nm. The approach is quick and cost-effective due to the low flow rate and short retention time. The linearity, accuracy, precision, robustness, LOD, and LOQ properties of this approach were all validated. At 80, 100, and 120 percent, the percent recovery was found to be 102.54, 100.65, and 101.04. The percent RSD of intra-day precision was determined to be 0.04, 0.04, and 0.03 whereas the percent RSD of interday precision was 0.07, 0.12, and 0.08. The method that was devised was unique. Cabozantinib had a retention time of 3.651 minutes. 0.0609ppm and 0.1845ppm were found to represent the LOD and LOQ, respectively.
... Solvating power of SCFs could be changed by varying some variables such as temperature and pressure. SFE is the most selective method for reducing the potential for oxidation that has been used in a variety of pharmaceutical and food matrices [34][35][36][37][38]. To make SFE a viable technique for widespread analytical application, the knowledge of the solubility of analytes in the fluid, the mass transfer mechanism, kinetics parameter, and restrictions of thermodynamics related to the extraction conducted in a matrix sample is necessary. ...
... To make SFE a viable technique for widespread analytical application, the knowledge of the solubility of analytes in the fluid, the mass transfer mechanism, kinetics parameter, and restrictions of thermodynamics related to the extraction conducted in a matrix sample is necessary. Meanwhile, understanding the effect of various variables on the extraction process is required [34][35][36][37][38]. ...
Super Critical Fluid is the emerging technique that consists of super solvent, which is considered a boon over many other conventional solvents. The main component utilized in it is Carbon Dioxide [CO2], which possesses dual state properties such as effusion through solid and other dissolving materials like liquid which results in unique applications bidden with no limitations. The varying temperature and pressure are the important parameters optimized and thus enhance its solvent properties. Higher Co-efficient of diffusion, reduction in time, higher compressibility, etc., is some of the major advantages of SCF-CO2 over the conventional solvents. Over and above, it is a green approach and a super solvent. Here we have discussed the multifarious applications of the SCF-CO2 extraction in fields and areas extended, but not limited to, Food, Environmental, Analysis, Metal-Cation Extraction, as well as Extractions, Forensics, Pharmaceuticals, Toxins, and Botanical Samples.
... A review of the literature revealed that only a few analytical methods for evaluating CBZ and NVB had been published. Liquid chromatography-mass spectrometry estimation [21,22] and enzyme-linked immunosorbent assay (ELISA) estimation [23] , forced degradation [24] and bio-analytical [20] studies by HPLC, CBZ estimation [25] by HPLC, are some of these approaches. However, no stability indicating HPLC methods for the analysis of related substances (RS) of CBZ and NVB in combined dosage forms have yet been published to our knowledge. ...
Developed method is a rapid, simple and Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method for determination of teriflunomide. The HPLC separation was achieved on Agilent-1260 Infinity series instrument with C18-5μm, Waters Column. (150X4.6 mm, 5μm) using a mobile phase of acetonitrile and water solution (40:60; v/v) at a flow rate of 1.0 ml/min. The method was validated for specificity, linearity, precision, accuracy, robustness and ruggedness. The elution of peak was rapid which takes about 10 minutes. The method was found to be simple, specific, precise, accurate, linear and reproducible. The method can be applied for the quality control of commercial teriflunomide API (active pharmaceutical ingredient) to quantify the drug and to check the formulation content uniformity and purity of drug.
Nanomaterials-based hybrid nano therapy is gaining attraction as a promising way to treat intracellular bacterial infections. Gold-based nanomaterials have been widely used for biomedical applications such as photothermal therapy (PTT). This thesis discusses the development of a combination therapeutic approach that kills intracellular bacteria in conjunction with photothermal and antibiotic therapy using gold nanorod (GNR) based nano-assembly. This NIR laser-activated nano-assembly delivers antibiotics to the site of infection and offers PTT. The synergistic application of both therapies increases the efficacy of treatment. The protected delivery of antibiotics and their release in the proximity of the bacterial surface decreases off-target toxicity and drug dosage. The core of the nano-assembly is composed of GNRs coated with a mesoporous silica shell (MS). The MS shell serves as a carrier for the anti-tuberculosis drug bedaquiline. The core-shell nanoparticle is encapsulated within a thermo-sensitive liposome (TSL). The TSL layer is further conjugated to the mycobacteria-targeting peptide NZX. NZX mediates the adhesion of the final nano-assembly onto the mycobacterial surface. Upon NIR laser irradiation GNRs convert the photon energy of the laser to localized heat, which melts the TSL, triggering the release of bedaquiline. The antibacterial activity of the final nano-assembly against Mycobacterium smegmatis (Msmeg) was 20 folds more efficacious than the free drug equivalent. Mtb can alter immune defense mechanisms exerted by the host macrophage. Hence, host-targeted nano-assemblies (HTNs) were fabricated by conjugating host targeting ligands (β-Glucan) onto the nano-assembly. The binding of β-Glucan conjugated HTNs to the dectin-1 receptor present on macrophages increases the free radical production and cellular uptake of HTNs. An NIR laser triggers the photothermally induced structural disruption of the nano-assembly, releasing the drug at the targeted sites. The released bedaquiline within the macrophage promotes phagosome acidification and phagolysosome formation, effectively killing 99% of intracellular bacteria. Similar nano-assemblies were developed for dual-targeted drug delivery against lung carcinoma and proved to be 20 fold more effective than the anticancer drug alone. Finally, a simple and rapid diagnostic test was developed for detecting mycobacteria within a minute using lectin conjugated multi-core silica-coated magnetic nanoparticles.
The objective of this method is to be simple, precise, and economical performed by LC-MS/MS instrument. The mass spectrometric determination was performed using electrospray ionization in the positive mode with multiple reaction monitoring (MRM) mode and precursor to product ion transition to product ion of m/z 502.2 > 323 for cabozantinib. The effective separation of cabozantinib was achieved X-Bridge (2.1 mm × 100 mm, 3.5 µ) column and the mobile phase composition is 0.2% formic acid: acetonitrile (40:60 v/v), pumped at 0.12 ml/min flow rate. The Rt of cabozantinib was found to be 1.34 minutes. The LOD and LOQ were found at 1.5 ng/ml and 5 ng/ml concentrations and linearity concentrations were in a range of 5 ng/ml to 75 ng/ml with a regression correlation coefficient of 0.999. The % RSD value of accuracy was observed at 1.2–2.0. The marketed formulation assay was found to be 99.82%. The developed method and validation parameters were accepted as per USFDA guidelines.
Environmental sustainable analytical methods were developed by mathematical modification of UV absorption spectra for quality control study of multicomponent formulations consisting of remogliflozin (REM) and teneligliptin (TEN), with good sensitivity and selectivity. Then analytes were quantified by measuring the peak amplitude of the first derivative spectra at zero crossing points at 230.2 nm and 213.8 nm for REG and TEN in the first derivative method. The second method involves the formation of ratio spectra and taking the absorption difference at two selected wavelengths of peak and trough of a spectrum. In the ratio first derivative method peak amplitudes were measured at 235.2 nm and 259.1 nm for simultaneous quantification of REM and TEN respectively. The fourth method was based on the measurement of the peak amplitude of zero-order spectra of analytes generated from the mixture spectrum by subtraction of a constant from the ratio spectrum followed by multiplication with divisor spectrum, Further, the proposed methods were validated systematically to confirm the linearity, precession, accuracy, sensitivity, and selectivity. Finally, validated UV spectroscopic methods were applied for simultaneous quantification of REM and TEN from formulation, and laboratory mixed solutions and statistically compared with the reported HPLC method. Further, recently developed AGREE, Hexagonal greenness and white analytical chemistry, a whiteness evaluation tools were applied to the proposed UV spectroscopic methods and found to be safer analytical methods, compared to the reported expensive, time-consuming and toxic HPLC method. Hence, proposed UV spectroscopic methods could be used for routine quality control of formulations containing REM and TEN.
Forced degradation tests are studies used to assess the stability of active pharmaceutical ingredients (APIs) and their formulations. These tests are performed submitting the API under extreme conditions in order to know the main degradation products in a short period of time. The results of these studies are used to assess the degradation susceptibility of APIs and to validate chromatographic analytical methods. However, most of degradation studies are performed using one-factor-at-the-time (OFAT) which does not consider the interactions between degradation variables. This work proposes the use of Design of Experiment (DoE) approach in forced degradation of albendazole (ABZ). It was used a central composite design (CCD) to evaluate the forced degradation in a multivariate way. Experiments were performed taking into account the variables pH, temperature, oxidizing agent (H2O2) and UV radiation. It was verified the influence of the variables and their interactions on the ABZ degradation. The ABZ oxidation showed to be the main degradation route for ABZ, which is strongly influenced by the temperature. The hydrolysis was relevant at alkaline medium and high temperature. LC-IT-MSⁿ was used to identify the degradation products. It was found three known degradation products (albendazole-2-amino, albendazole sulfoxide and albendazole sulfone) and a new derivate of albendazole molecule (albendazole sulfoxide with a chlorine). This last one was isolated and characterized by UPLC-QToF-MS and NMR analyses.
