Nitroso impurities are a class of chemical contaminants that contain the nitroso group (–NO) and typically act as genotoxic agents. Hence, it is necessary to develop a sensitive and reliable analytical method for their accurate quantification to ensure drug safety and regulatory compliance. A Quality by Design (QbD) approach was systematically applied to develop and optimise a method for the separation and simultaneous quantification of elacestrant and its nitroso impurities. In method development, various column types and mobile phase compositions were screened based on the physicochemical properties of analytes, followed by utilising central composite design and response surface methodology. The critical method parameters, such as buffer composition and pH, were identified as key factors that affect the resolution and retention. Several experimental runs were analysed through 3D surface plots and contour graphs to fine-tune the conditions for the effective resolution of elacestrant and its impurities. The finalised method uses a Shim-pack C18 column at 35°C with a mobile phase of 10 mM ammonium acetate buffer (pH 4.3) and acetonitrile in a 65:35 (v/v) at 1.0 mL/min and detection at 238 nm. The method shows excellent linearity (R² > 0.999) across the tested concentration ranges for both elacestrant and its impurities. Precision studies show low %RSD values confirm the method’s reproducibility. The high recovery rates (98–102%) at multiple recovery levels demonstrate the method’s accuracy. The method shows high sensitivity with low detection and quantification limits, suggesting the method’s suitability for trace-level quantification of impurities. Forced degradation experiments confirm the stability-indicating capability of the method with no interference or co-elution of analytes. Major Findings: The developed QbD-based stability-indicating RP-HPLC method was found to be sensitive, precise, accurate, robust, and suitable for routine quality control, stability assessment, and regulatory monitoring of elacestrant and its genotoxic nitrosamine impurities in pharmaceutical formulations.
Pesticides are extensively used in agricultural and domestic settings, raising concerns about their potential to induce oxidative stress and associated health risks. The present study investigates the impacts of acute and chronic exposure to pesticides, alone and in mixtures, and measures their harmful effect by assessing changes in Thiobarbituric AcidReactive Substances (TBARS) levels in various rat tissues. The study examines how two Organophosphate (OP) pesticides (monocrotophos and chlorpyrifos) and two Organochlorine (OC) pesticides (lindane and endosulfan), given alone or together, affected TBARS levels in rat tissues. Rats received 1.8mg Monochrotophos (MCP), 15.5mg Chlorpyrifos (CPF), 10mg Endosulfan (ENS), and 8.8mg Lindane (LND)/kg body weight (equal to 1/10 Lethal Dose (LD50)), mixed in 0.4ml peanut oil. Additionally, the protective role of antioxidant vitamins (vitamin A: 2.0 μg, vitamin E: 20.0 μg, and vitamin C: 120 μg/kg body weight) was assessed through pre-treatment prior to pesticide exposure. Results from both acute and chronic administration showed a significant, dose-dependent rise in TBARS levels. It was observed that the joint administration of pesticides caused more oxidative damage than the single administration of the pesticides. Pretreatment of the animals with antioxidants showed a reduction in TBARS levels, indicating their protection against oxidative damage. In conclusion, the results clearly demonstrate that the effect of pesticides on oxidative stress is dose-dependent, especially during exposure in combination, whereas vitamin supplements can be used as a possible approach to counteract these adverse effects. Major Findings: Combined pesticide exposure significantly increased TBARS levels across all examined tissues in a doseand duration-dependent manner, with greater oxidative damage than individual pesticide exposure. Pretreatment with vitamins A, C, and E substantially reduced TBARS levels, although values remained above controls, indicating partial protection against pesticide-induced oxidative stress.
Mercury (Hg) exposure remains a major environmental health concern because of its persistence, bioaccumulation potential, and adverse effects on vulnerable populations, particularly pregnant women, fetuses, and newborns. Although bibliometric studies on Hg have been conducted in several domains, the research landscape specifically addressing Hg exposure in relation to pregnancy, fetal development, and newborn health has not been clearly mapped. This study aimed to provide a global bibliometric overview of scientific publications on this topic indexed in the Scopus database from 2014 to 2023. Literature retrieval was conducted using the Publish or Perish (PoP) application, and bibliometric mapping was performed using VOSviewer. A total of 200 publications were included in the final analysis, yielding 23,458 citations, an H-index of 87, and a G-index of 141. The United States and China were the leading contributing countries, while Environment International, Environmental Research, and Environmental Health Perspectives were the major journals publishing studies in this field. Keyword mapping showed that the literature was mainly concentrated around pregnancy-related mercury exposure, methylmercury, neurodevelopmental outcomes, and endocrine or metabolic themes. In contrast, fetus- and newborn-specific outcomes appeared less densely represented, indicating the need for more targeted bibliometric investigations. However, the analysis did not systematically classify studies by pregnancy trimester, gestational age, specific clinical outcomes, or regional subsets.
The production of metallic nanoparticles, especially Copper nanoparticles (CuNPs), has gained interest over the last few years. CuNPs with their unique physical and chemical properties can have both positive and negative effects, and therefore, the appropriate dosing concentration of CuNPs is important. The present research reports the production of CuNPs through a green synthesis method using Burkholderia sp. (NCBI Accn. No. OP646862). Biosynthesis parameters were optimized at 1 mM copper sulphate, with a 2:3 ratio of bacterial supernatant to copper solution, pH 8 and 48 h of incubation. The CuNPs showed a peak at 540 nm; Fourier transform infrared spectroscopy indicated proteins, amino acids, alkene and amine groups; Field-emission electron microscopy showed spherical particles; XRD indicated a crystalline size of 24.10 nm and the zeta size was 141.5 nm with moderate stability (−20.04 mV). The synthesized nanoparticles were checked for any phytotoxic effect on seed germination of V. radiata and V. mungo. However, at concentrations higher than 80 ppm, slight decline in radicle length was observed in both Vigna species. The optimum concentration that can be used for plant growth promotion is 40 ppm and 60 ppm in V. mungo and V. radiata respectively. While, higher concentration can be used to control plant pathogens as 100% seed germination in both the Vigna species. Major Findings: CuNPs was successfully synthesized using Burkholderia species. CuNPs-primed seeds of both Vigna species showed 100% germination, hence there is no toxicity of the CuNPs, however, decrease in radicle length indicate phytotoxic effects above 80 ppm.
Oral submucous fibrosis (OSMF) is a long-standing, progressive disorder with a high risk of malignancy, characteristically linked with inflammation, resulting in progressive fibrosis of submucosal tissues, and disturbed oxidant-antioxidant homeostasis. Nano-curcumin has been found to enhance Objective Response Rate (ORR) with high statistical relevance, along with a remarkable reduction in lesion size and lesion grade downstaging. Levels of Superoxide Dismutase showed substantial improvement with nano-curcumin in the test group subjects. The difference in mouth opening was evident in all patients (p = 0.0005), and improvements in serum SOD levels (p = 0.0004) were observed in the test group. The control group showed no statistically significant change in mouth opening (p = 0.7824) or serum SOD levels (p = 0.562). Disease grade improvement occurred in 53.33% of treated patients versus 0% of controls. Complete prodromal symptom remission was achieved in 100% of nano-curcumin recipients compared to 0% in the placebo group. In summary, nano- curcumin significantly enhances antioxidant anti-fibrotic capacity, improves clinical parameters, and achieves disease grade reversal in OSMF patients. These findings establish nano-curcumin as a safe, effective, natural therapeutic modality for this potentially malignant disorder, warranting consideration as first-line or adjunctive treatment in clinical practice.
