Commercial Formulations Research Articles

A novel RP-HPLC method for the simultaneous quantification of azithromycin and dexamethasone in marketed ophthalmic drops

A straightforward, precise, accurate, specific, and sensitive RP-HPLC technique has been established for the quantification of Azithromycin Dihydrate and Dexamethasone Sodium Phosphate in their commercial formulation. The wavelength maxima for Azithromycin and Dexamethasone were considered to be 215 nm for estimation. In RP-HPLC separations were carried out on a Zorbax SB C18 column (250mm X 4.6mm, 5 μm) and mobile phase consisting of Acetonitrile: Monobasic Potassium Phosphate (KH2PO4) buffer in the proportion of 75:25 v/v and pH of the buffer was adjusted to 5.5 with OPA. The estimation was carried out at 215 nm using UV detector keeping the flow rate of 1.2 ml/min and injection volume of 50 μl. The current method demonstrates good linearity over the range of 20 - 120 μg/ml and 2 - 12 μg/ml for Azithromycin and Dexamethasone respectively. No interference of excipients was found during estimation. The recommended techniques were verified and determined to be specific, accurate, and exact. The approaches were effectively used for the concurrent quantification of both medicines in pharmaceutical formulations, making them suitable for regular quality control examination.

Effects of graphene content on formation and characteristics of char layer in intumescent coating

This study provides a better understanding of the role and mechanism of graphene nano-platelets used as a flame-retardant filler in a commercial intumescent acrylic-based formulation. Through thermogravimetric analysis, the morphology and mechanical properties of the char layer as well as the influence of graphene on the expansion ratio and compression force are clarified. The achieved results demonstrate that graphene accelerates the burning of the coating and affects the structure of the char layer. The fire test was carried out in an electric furnace at a temperature of up to 800 °C for our fabricated samples, the swelling images show that the expansion ratio of the graphene-loaded coating is lower than that of the coating without graphene. On the other hand, during the combustion, the speed of air release occurring in a short time also contributes to forming bigger holes in the char layer, so the hardness of the graphene-loaded char layer is lower than that of the char layer without graphene coating.

Individual and combined effects of commercial glyphosate, atrazine and 2,4-D herbicides on the gerbil ventral prostate

Exposure to pesticides, individually or in a mixture, in drinking water is one of the main sources of human contamination, which causes adverse effects on the reproductive system. Our study aimed to investigate, the effects of a 90-day exposure to low concentrations of glyphosate (GLY), atrazine (ATZ), and 2,4-dichlorophenoxyacetic acid (2,4-D), in commercial formulations, on morphological, molecular, and hormonal parameters of the ventral prostate of gerbils (Meriones unguiculatus). The animals were exposed via drinking water to individual concentrations of GLY: 700 μg/L, ATZ: 3 μg/L, and 2,4-D: 70 μg/L, as well as to their mixture (MIX). Our findings showed an increase in prostatic complex relative weight in ATZ-exposed animals. Stereological and morphometric techniques indicated an increase in the percentage and thickness of muscular stroma, following an increase in the amount of collagen and reticular fibers in the MIX group. Histopathological analysis showed a decrease in the incidence of epithelial atrophy, subepithelial inflammation, and microacini in the MIX. On the other hand, ATZ-exposed animals showed an increase in hyperplasia and total prostatic intraepithelial neoplasia (PIN). The expression of caspase-3 decreased and estrogen receptor alpha (ERα) increased in the 2,4-D and MIX. Western blotting showed an increase in estrogen receptor beta (ERβ) expression in MIX-exposed animals. Testosterone levels decreased in animals from the GLY, ATZ and 2,4-D groups. Our findings provide evidence that individual or combined exposure to herbicides causes hormonal imbalance and morphological alterations, besides favoring the incidence of proliferative lesions in the prostate, predisposing the gland to more severe injuries.

Ecotoxicity of bioinsecticide spinosad to soil organisms: Commercial formulation versus active ingredient

Spintor® (SPIT®) is a commercial formulation of a bioinsecticide with the active ingredient Spinosad (SPIN). Despite the efforts of regulatory agencies, there still is a lack of information regarding short- and long-term exposures to soil-dwellers, as well as effects at environmentally relevant concentrations. This work aimed to evaluate the effects of SPIT® and SPIN, on the oligochaete Eisenia fetida, and the arthropod Folsomia candida. For this, natural soil was spiked with environmentally relevant concentrations (0.00–1.49 mg of the active ingredient·kg−1 of dry soil) to assess avoidance behaviour in E. fetida and reproduction effects on both species. Further, in E. fetida adults exposed for 2- and 28-day biomarkers of oxidative stress, energetic reserves, neurotoxicity and genotoxicity were evaluated. A significant reduction in juvenile production for F. candida was observed for SPIT® at ≥0.66 mg kg−1 and SPIN at ≥0.13 mg kg−1, and although no effect was observed on E. fetida reproduction, the oligochaeta revealed a tendency to avoid soil spiked with SPIT® at 0.44, 0.66 and 1.49 mg kg−1. The sub-individual responses of E. fetida demonstrate genotoxicity upon exposure to SPIT® and SPIN for 2 days. The 2-day exposures of SPIT® and SPIN seem to induce defence mechanisms, and in general, SPIN exerted higher effects than SPIT® on the oligochaetes. Overall, the pro-oxidant performance and energy metabolism pathways were disrupted in both exposures to SPIT® and SPIN. The results suggest that spinosyns-based products can have an impact on soil arthropods F. candida and oligochaete's health, possibly affecting their essential functions in terrestrial ecosystems.

Small-Molecule Therapeutics Achieve Multiple Mechanism-Mediated Sensitizations of Colorectal Cancer to Immune Checkpoint Blockade via Neutrophil Micropharmacies.

Immune checkpoint blockade (ICB) therapy has been approved for colorectal cancer (CRC). However, response rates are variable and often <50%. The low tumor immunogenicity and immunosuppressive tumor microenvironment (TME) jointly contribute to this suboptimal response rate. This study confirmed the potential of combining immunogenic cell death (ICD) inducer irinotecan (IRI) and transforming growth factor-β (TGF-β) inhibitor galunisertib (GAL) to improve tumor immunogenicity and remodel the immunosuppressive TME. Moreover, to ameliorate the in vivo delivery barriers associated with small molecules, neutrophil micropharmacies (NOG) were developed for the codelivery of IRI and GAL, which loaded the commercial liposome formulation of IRI (ONIVYDE, ONI) intracellularly and conjugated the pH-responsive GAL liposome (GLP) on the cell surface. This neutrophil-based formulation resulted in a >4-fold increase in the ratios of the amount of both IRI and GAL accumulated in tumors to the dosage administration, effectively achieving multiple mechanism-mediated sensitization of CRC to ICB therapy.

In situ photocrosslinkable hydrogel treats radiation-induced skin injury by ROS elimination and inflammation regulation

The clinical management of radiation-induced skin injury (RSI) poses a significant challenge, primarily due to the acute damage caused by an overabundance of reactive oxygen species (ROS) and the ongoing inflammatory microenvironment. Here, we designed a dual-network hydrogel composed of 5 % (w/v) Pluronic F127 diacrylate and 2 % (w/v) hyaluronic acid methacryloyl, termed the FH hydrogel. To confer antioxidant and anti-inflammation properties to the hydrogel, we incorporated PVP-modified Prussian blue nanoparticles (PPBs) and resveratrol (Res) to form PHF@Res hydrogels. PHF@Res hydrogels not only exhibited multiple free radical scavenging activities (DPPH, ABTS), but also displayed multiple enzyme-like activities (POD-, catalase). Meanwhile, PHF@Res-2 hydrogels significantly suppressed intracellular ROS and promoted the migration of fibroblasts in a high-oxidative stress environment. Moreover, in the RSI mouse model, the PHF@Res-2 hydrogel regulated inflammatory factors and collagen deposition, significantly reduced epithelial hyperplasia, promoted limb regeneration and neovascularization, and accelerated wound healing, outperforming the commercial antiradiation formulation, Kangfuxin. The PHF@Res-2 hydrogel dressing shows great potential in accelerating wound healing in RSI, offering tremendous promise for clinical wound management and regeneration.

Development, Validation, and Greenness Assessment of Eco-Friendly Analytical Methods for the Determination of Abiraterone Acetate in Pure Form and Pharmaceutical Formulations

This study presents the development and validation of environmentally friendly analytical methods for quantifying Abiraterone Acetate (AA) in both its pure form and commercial pharmaceutical formulations. An optimized High-Performance Liquid Chromatography (HPLC) method was developed using an Agilent Extend C18 column (250 mm × 4.6 mm, 5 μm) at 25 °C. The mobile phase consisted of formic acid and ethanol in isocratic mode, with a flow rate of 1.0 mL min−1, and detection was performed at 253 nm. The spectrophotometric method involved a comprehensive evaluation of AA’s spectral properties in various solvents, with ultrapure water providing the most suitable spectra for analysis at 253 nm. Both methods were validated according to ICH guidelines, demonstrating selectivity, linearity, accuracy, precision, detection and quantification limits, and robustness, with correlation coefficients exceeding 0.999 across the 5–30 μg mL−1 concentration range. Comparative statistical analysis using Student’s t-test and Fisher’s F-test showed no significant differences between the two methods. The environmental impact of both methods was assessed using AGREE and GAPI software, confirming their sustainability. These validated methods offer reliable and eco-friendly approaches for the quantitative analysis of AA in tablet formulations, promoting safer and greener laboratory practices in pharmaceutical analysis.

Residual effect of commonly used insecticides on key predatory mites released for biocontrol in strawberry.

Florida is the second largest producer of strawberries in the United States. However, the production system faces numerous challenges, especially Scirtothrips dorsalis Hood (Thysanoptera: Thripidae) infestations. Management of this pest involves applying insecticides and use of predatory mites, particularly Amblyseius swirskii Athias-Henriot, Neoseiulus cucumeris Oudemans, and Neoseiulus californicus McGregor (Mesostigmata: Phytoseiidae). Strawberry growers in Florida are concerned about the compatibility of the commercial formulations of insecticides used in strawberry pest management with predatory mites. This study assessed the residual effect of commercial insecticides used in strawberry production on the survival, feeding, and oviposition of the 3 predators. Using Munger cells, predators were exposed to commercial formulations of spinetoram, cyantraniliprole, azadirachtin + pyrethrin, Beauveria bassiana, Cordyceps javanica, capsicum, garlic, and canola oil extracts, and water control. There was a gradual decline in the survival and feeding of predatory mites when exposed to all insecticides. Spinetoram had the highest impact on the survival and feeding of all predators compared to other insecticides, while C. javanica had the lowest impact. Cyantraniliprole and azadirachtin + pyrethrin significantly reduced predator survival after 72h of exposure, whereas capsicum, garlic, and canola oil extracts caused a similar reduction after 96h. All predators consumed low proportions of S. dorsalis across all treatments. Oviposition was low in all treatments, with no discernable variation among treatments. These results highlight the potential of using entomopathogenic fungi in conjunction with A. swirskii, N. cucumeris, and N. californicus for the management of S. dorsalis and T. urticae in strawberries.

An injectable hydrogel of porcine cholecyst extracellular matrix for accelerated wound healing.

Hydrogel formulations of xenogeneic extracellular matrices have been widely used for topical wound care because of their exceptional tunability over other formulations like lyophilized sheets, powders, non-injectable gels, pastes, and ointments. This is important in the treatment of wounds with irregular shapes and depth. This study identified an injectable hydrogel formulation of porcine cholecyst extracellular matrix (60%) in medical-grade carboxymethyl cellulose (40%) as vehicle and evaluated its biomaterial properties. Further, an in-depth evaluation of in vivo wound healing efficacy was conducted in a rat full-thickness skin excision wound healing model, which revealed that the hydrogel formulation accelerated wound healing process compared to wounds treated with a commercial formulation and untreated wounds. The hydrogel appeared to have promoted a desirable pro-regenerative tissue reaction predominated by Th2 helper lymphocytes and M2 macrophages as well as an effective collagen remodeling indicative of diminished scarring. In conclusion, the porcine cholecyst extracellular matrix injectable hydrogel formulation appeared to be a promising candidate formulation as an advanced wound care biomaterial for faster healing of skin wounds with minimal scarring.

Growth, nutrient uptake and yield ofdirect seeded rice as influenced by weed management practices

A field experiment was conducted during the rainy (Kharif) seasons of 2018 and 2019 at the Kerala Agricultural University, Kerala, to evaluate the effect of herbicides and herbicide combinations on the weed management and growth, nutrient uptake and yield of direct seeded rice (DSR). The experiment was laid out in a randomized block design with three replications. Nine weed control treatments were used, including sole application of three herbicides (cyhalofop butyl @ 80 g/ha, bispyribac sodium @ 25 g/ha, fenoxaprop-p-ethyl@ 60 g/ha), five herbicidal combinations (penoxsulam + cyhalofop butyl commercial formulation @ 150 g/ha, cyhalofop butyl @ 80 g/ha + carfentrazone ethyl @ 200 g/ha, bispyribac sodium @ 25 g/ha + cyhalofop butyl @ 80 g/ha, bispyribac sodium @ 25 g/ha + fenoxaprop-p-ethyl @ 60 g/ha and stale seedbed followed by (fb) glyphosate @ 800 g/ha + oxyfluorfen @ 150 g/ha at 15-20 days after land preparation + cyhalofop butyl @ 80 g/ha + carfentrazone ethyl @ 200 g/ha), and hand weeding twice at 20 and 40 days after sowing. Weeds removed 27.72, 4.61 and 67.95 kg of N, P and K/ha respectively at 45 days after treatment application (DATA) under unweeded conditions in direct seeded rice. Herbicidal treatments enhanced grain yield by 23.89 to 58.84 % and herbicide combinations increased grain yield by 56 to 59 % compared to the unweeded control in direct seeded rice. Tank mix combination of bispyribac sodium @ 25 g/ha + fenoxaprop-p-ethyl @ 60 g/ha and bispyribac sodium @ 25 g/ha + cyhalofop butyl @ 80 g/ha and premix combination of penoxsulam + cyhalofop butyl @ 150 g/ha recorded higher nutrient uptake and grain yields (5.03, 4.76 and 4.79 t/ha, respectively) and were on par to hand weeding twice. Unweeded control recorded the lowest pooled grain yield (2.07 t/ha) and uncontrolled weed competition resulted in 59.95 % reduction in grain yield. Keywords: Crop competition, Herbicide combinations, Herbicide interactions, Nutrient removal, Nutrient uptake, Yield reduction

Cytotoxicity induced by three commercial neonicotinoid insecticide formulations in differentiated human neuroblastoma SH-SY5Y cells.

Neonicotinoid insecticides are used worldwide for crop protection. They act as agonists at postsynaptic nicotinic acetylcholine receptors (nAChRs), disrupting normal neurotransmission in target insects. Human exposure is high due to the widespread use of neonicotinoids and their residues in food. This study aimed to evaluate the in vitro neurotoxicity of three neonicotinoid commercial formulations Much 600 FS® (imidacloprid 600gL-1), Evidence 700 WG® (imidacloprid 700gkg-1), and Actara 250 WG® (thiamethoxam 250gkg-1) in differentiated human neuroblastoma SH-SY5Y cell line. Cells were incubated with the pesticides for 96h, and the cytotoxicity was evaluated through the 3-(4,5-dimethyl-2-thiazolyl)-2,5-diphenyl-2H-tetrazolium·bromide (MTT) reduction and neutral red (NR) uptake assays. Toxicological pathways such as reactive oxygen (ROS) and nitrogen species (RNS) production, mitochondrial membrane potential, cell death mode, and the expression of the pro-apoptotic protein Bax were also evaluated. EC50 values of 266.4, 4,175, and 653.2mgL-1 were found for Much®, Evidence® and Actara®, respectively. Significant increases in ROS and RNS generation were observed for all pesticides, while mitochondrial membrane potential and Bax protein expression showed no significant changes. Analysis of cell death mode revealed an increase in early apoptotic cells. Therefore, neonicotinoid insecticides are potentially neurotoxic, reinforcing concerns about human exposure to these commercial formulations.

Prolonged Skin Retention of Luliconazole from SLNs Based Topical Gel Formulation Contributing to Ameliorated Antifungal Activity.

The development of effective therapy is necessary because the patients have to contend with long-termtherapy as skin fungal infections usually relapse and are hardly treated. Despite being a potent antifungal agent, luliconazole (LCZ) has certainshortcomings such as limited skin penetration, low solubility in aqueous medium, and poor skin retention. Solid Lipid Nanoparticles (SLNs) were developed using biodegradable lipids by solvent injection method and were embodied into the gel base for topical administration. After in-vitro characterizations of the formulations, molecular interactions of the drug with excipients were analyzed using in-silico studies. Ex-vivo release was determined in contrast to the pure LCZ and the commercial formulation followed by in-vivo skin localization, skin irritation index, and antifungal activity. The prepared SLNs have an average particle size of 290.7nm with no aggregation of particles and homogenous gels containing SLNs with ideal rheology and smooth texture properties were successfully prepared. The ex-vivo LCZ release from the SLN gel was lower than the commercial formulation whereas its skin deposition and skin retention were higher as accessed by CLSM studies. The drug reaching the systemic circulation and the skin irritation potential were found to be negligible. Thesolubility and drug retention in the skin were both enhanced by the development of SLNs as a carrier. Thus, SLNs offer significant advantages by delivering long lasting concentrations of LCZ at the site of infection for a complete cure of the fungal load together with skin localization of the topical antifungal drug.

Quantitation of Usnic acid from three Usnea species, its commercial formulations Using High-Performance Thin-Layer Chromatography-Mass Spectrometry (HPTLC-MS) and their metabolite profiling using UPLC-QTof-MSE.

The genus Usnea (Parmeliaceae; lichenized Ascomycetes) is pale grayish-green fruticose lichens which grow as leafless mini-shrubs and comprise about 360 species. Most of the Usnea species are edible and is utilized in preparation of traditional foods as well as in medicines to combat wide range of ailments. The goal of this work was to quantify usnic acid in three Usnea spp. [Usnea ghattensis (UG), Usnea orientalis (UO) and Usnea undulata (UU)] using HPTLC-MS and chemical profiling of acetone extracts using UPLC-QTof-MSE resulted in the identification of sixteen compounds based on their MS/MS fragmentation patterns. Hyphenated techniques, HPTLC-MS and UPLC-QTof-MSE have been proposed to quantify usnic acid and analysis of metabolites in the crude extracts qualitatively. This method allowed tentative characterization of metabolites from Usnea spp. The quantification study showed the excellent linearity of the usnic acid at 0.25-1 µg/band with a correlation coefficient r 2>0.99, and LOD, LOQ was found to be 51.7 and 156.6 ng/band, respectively. Further, UPLC-QTof-MSE analysis of crude extract led identification of lichen substances through their exact molecular masses and MS/MS fragmentation studies. The present study summarizes HPTLC method for quantification of usnic acid in three different Usnea spp. Along with two herbal formulations containing Usnea spp. as the ingredient and developed method was validated as per the ICH guidelines and further UPLC-QTof-MSE analysis provides characterization of the sixteen different secondary metabolites based on their mass fragmentation studies. Rapid HPTLC method for quantification of usnic acid in three different Usnea spp. along with two herbal formulations and metabolite profiling using UPLC-QTof-MSE.

Changes in drug crystallinity in a commercial tacrolimus amorphous formulation result in variable pharmacokinetics

Tacrolimus capsules contain the drug as the amorphous form. It is well known that drug crystallinity is a risk factor for the performance of amorphous formulations. This study investigated the impact of varying levels of crystalline drug on the pharmacokinetics of tacrolimus following oral dosing of a 5 mg capsule under fasting conditions. Two treatments with percent crystallinity of 20% and 50% were achieved by exposing a marketed generic tacrolimus product to open dish storage conditions of 35 °C and 75% relative humidity (RH) for up to 20 days. Crystallinity was monitored with X-ray powder diffraction. Prograf®, the reference listed drug (RLD), an amorphous generic drug product, and generic drug products containing 20% and 50% crystalline tacrolimus were evaluated. All four treatments were administered to healthy participants in a randomized, single-dose, four-treatment, four-period, four-way crossover study. Blood sampling occurred over 24 h. The amorphous generic tacrolimus product was determined not to be bioequivalent to the RLD. The capsules containing both 20% and 50% crystalline tacrolimus also failed the bioequivalence recommendations when compared to the amorphous generic or to the RLD. Both levels of crystalline tacrolimus resulted in BE failure for both Cmax and AUC parameters. The impact of tacrolimus crystallization was greater for maximum blood concentration (Cmax) values relative to the area-under-the-curve (AUC) values. This study demonstrates that crystalline tacrolimus formed in a marketed generic product and these changes resulted in variable pharmacokinetics which could be of significant clinical concern.

Advanced scattering techniques for characterisation of complex nanoparticles in solution

Nanoparticles are vital to a broad range of applications including commercial formulations, sensing and advanced material synthesis. Nanoparticles can come in a variety of shapes including cubes, polyhedra, rods, and prisms, and recent literature has demonstrated the importance of nanoparticle shape to downstream function (such as cellular uptake). While researchers routinely characterise nanoparticle shape using electron microscopy techniques, this generally requires drying of the samples. Many particles (e.g. lipid nanoparticles or polymer particles) change with drying, so complementary solution based techniques are needed. Scattering techniques can be used to characterise such nanoparticles in suspension, overcoming many of the limitations of other techniques. Here we review the current state of the art in the characterisation of complex nanoparticles (non-spherical and multi-layered) using advanced scattering techniques including light, X-ray, and neutron scattering. Recent improvements in instrument availability and data analysis makes these techniques much more accessible to researchers. This review provides an introduction to these techniques aimed at all researchers working with nanoparticles, in the hope that full characterisation of nanoparticles in solution becomes standard practice.

Pharmacokinetic Analysis of Gatifloxacin and Dexamethasone in Rabbit Ocular Biofluid Using a Sensitive and Selective LC-MS/MS Method.

Bacterial keratitis (BK) is an infection that causes inflammation of the cornea and, if severe, can result in blindness. Topical fluoroquinolones combined with corticosteroids have been shown to be useful in the treatment of BK. A rapid, selective, and sensitive bioanalytical method for simultaneous quantification of Gatifloxacin (GAT) and Dexamethasone (DEX) has been developed and validated using tandem mass spectrometry (LC-MS/MS). Optimal separation was accomplished in under 5 min using an Agilent Zorbax C18 column (100 mm × 4.6 mm, 3.5 μm). The mobile phase was composed of a blend of 0.2% formic acid in triple distilled water and methanol with a flow rate of 0.65 mL/min in isocratic mode. GAT and DEX were detected in positive electrospray ionization multiple reaction monitoring mode (MRM), and the retention time was found to be at 1.64 and 2.93 min, respectively. The linearity of GAT and DEX was found to be in the range of 1.56-400 ng mL-1 with good precision and accuracy. The method was validated according to USFDA regulatory guidelines. The validated method was effectively utilized for preclinical pharmacokinetic analysis of GAT and DEX in rabbit tear fluid following the topical application of a commercial formulation.

Enhancement of bud dormancy release and development, leaf nutrition, flower and fruit quality of kiwifruit cv. ‘Hayward’ induced by BUD 14 biostimulant

The aim of this research was to investigate the influence of a foliar fertilization program, consisted of the BUD 14 nitrogen-calcium commercial formulation (N: 14% w/w, CaO: 5.5% w/w) as a biostimulant, on bud development percentage, flowering rate, classification of flowers into open, closed and triple, flower and pollen quality traits, fruit quality attributes, and leaf nutritional status of the ‘Hayward’ kiwifruit cultivar. The study was realized during a two-year experimental period in Naoussa, Central Macedonia, Greece. The results showed that BUD 14 induced synchronization in bud development relative to different vegetative stages including initiation of bud expansion, appearance of leaf apices covered by hair and deployment of 2-8 leaves and increased the flowering rate of open flowers. Pedicel length, ovary fresh weight, and dry weight, dry matter and length in female flowers as well as maximum pollen grain diameter and area in polar view in male flowers were significantly enhanced in the BUD 14 treatment. Fruit quality characteristics like average weight and dry mass were significantly augmented, and a 1.5-fold and 2-fold increase was recorded in canes length and number of kiwifruits per cane. In addition, leaf nutrient Ca and Mg concentrations were significantly enhanced, compared to the control. The efficacy of BUD 14 as a more target-oriented and environmentally friendly alternative method of supplying plants with smaller and controlled amounts of nutrients for breaking bud dormancy and improving their development was demonstrated, enhancing flower and fruit quality, leaf nutrition, kiwifruit developmental characteristics, and finally the total production per fruit per tree.

HPTLC Densitometric Analysis for Quantification of Sennocide-B and Rhein in Leaf Extracts of Senna alexandrina Mill. and Their Commercial Formulations.

The leaf extract of Senna alexandrina Mill., a plant from the Fabaceae family, contains bioactive anthraquinones sennoside-B and rhein, traditionally used in Indian medicine for various health issues. However, standardizing the quality of S. alexandrina and its commercial products is challenging. To address this, we established two high-performance thin-layer chromatography (HPTLC) methods for accurate analysis of these biomarkers in S. alexandrina leaf extract and its commercial formulations. For sennoside-B, a mobile phase combination of solvent for example, butanol, water, and glacial acetic acid (6:3.5:0.5, v/v/v) was used, with detection at 254 nm, producing spots at an Rf value of 0.37 ± 0.006. The method showed linearity between 100 to 2000 ng/spot (R² = 0.9983 ± 0.0017), with a limit of detection (LoD) of 22.84 ± 0.554 ng/band and a limit of quantitation (LoQ) of 69.22 ± 0.859 ng/band. For rhein, a mobile phase combination of solvent toluene, ethyl acetate, and glacial acetic acid in the ratio (7:2.5:0.5, v/v/v) was utilized and was also detected at 254 nm. The obtained spots had Rf value of 0.67 ± 0.004. The linearity was confirmed within the same range (R² = 0.9985 ± 0.0005), with an LoD of 15.49 ± 0.645 ng/spot and an LoQ of 46.94 ± 1.172 ng/spot. Herein, the methods have followed the guidelines of ICH (Q2) R1. These developed HPTLC methods are selective, simple, sensitive, accurate, and economical, making them suitable for everyday assessment of these bioactive markers in S. alexandrina and its commercial products. This study supports the quality control of S. alexandrina, ensuring product consistency, efficacy, and safety.

Eco(geno)toxicity of an acaricidal formulation containing chlorpyrifos, cypermethrin, and fenthion on different plant models and Artemia salina L.

The mixture of pesticides is widely employed in cattle farming to combat ectoparasite resistance, such as ticks. The commercial formulation COLOSSO FC30, which contains three active ingredients (Cypermethrin, Chlorpyrifos, and Fenthion), stands out due to its efficiency. However, animals exposed to this product may become vectors of potentially toxic molecules, possibly causing contamination in aquatic and terrestrial ecosystems. In light of this, this study evaluated the eco(geno)toxic potential of the commercial formulation COLOSSO FC30, using plants (Allium cepa L., Lactuca sativa L., Raphanus sativus L., Pennisetum glaucum L., and Triticum aestivum L.) and Artemia salina L. as model organisms. In the phytotoxicity test, the species were ranked in order of sensitivity to the commercial formulation as follows: P. glaucum > L. sativa > T. aestivum > R. sativus. The most sensitive parameters were root length (RL) and shoot length (SL) of seedlings. In the cytogenotoxicity test with A. cepa, cell division was decreased at concentrations from 0.351mL L-1 in the meristematic region and root F1. Chromosomal aberrations and micronucleus were observed at all concentrations. In the test with A. salina, the IC50 after 24h of exposure was 0.01207mL L-1 of the commercial formulation. The results highlight the need for further research and regulations to understand and minimize the potential environmental impacts of COLOSSO FC30.

Development and validation of High-Performance Thin Layer Chromatographic methods for simultaneous determination of antibacterial pharmaceutical formulations containing Clindamycin phosphate.

The main objective of this research is to establish and authenticate the High-Performance Thin-Layer Chromatographic techniques for the simultaneous assessment of Clindamycin phosphate in combination with Tretinoin (formulation-1) and Clindamycin phosphate with Adapalene (formulation-2), both of which are antimicrobial combinations. In the developed HPTLC methods, for combination-1, the optimized mobile phase was a mixture of n-Hexane: Ethyl acetate: ACN: Methanol (5:2:2:1 by volume) with observed Rf values of 0.413 and 0.787 for Clindamycin phosphate and Tretinoin, respectively. Similarly, for combination-2, the mobile phase comprised n-Hexane: Diethyl ether: Dichloromethane: Acetic acid (4:4:2:0.1 by volume) with recorded Rf values of 0.407 and 0.559 for Clindamycin phosphate and Adapalene, respectively. The developed methods are successfully validated as per the regulatory guidelines. This approach proves to be significantly time-saving and costeffective, rendering it suitable for routine analyses of the formulations containing selected antibacterial active pharmaceutical ingredients and commercial formulations.