Drug Research Articles

Ivermectin-based products in the context of green pharmaceutical analysis

Abstract Background Ivermectin (IVE), a broad-spectrum antiparasitic, is used in human and animal health. Analytical methods for evaluating IVE in pharmaceutical products are found in the literature and in official compendiums. However, the vast majority of them do not have an eco-friendly approach. Objective and Method The aim of this review is to present an overview of existing analytical methods for evaluating IVE in pharmaceutical matrices in the context of Green Analytical Chemistry (GAC) and show possibilities for increasing their greenness. Results GAC is a current alternative to promote sustainable development in laboratories and chemical-pharmaceutical industries, therefore, through its principles, such as reducing the use of aggressive solvents, it is possible to make processes more ecological. However, the vast majority of analytical methods available in the literature and official compendiums do not present an eco-friendly approach. 70% of the methods are by HPLC. Among the various pharmaceutical matrices, the most evaluated are tablets (37%). Of all the solvents used in HPLC, UPLC, HPLC-MS/MS, UV and TLC methods, the combination of methanol and acetonitrile is the most chosen, accounting for more than 50% of occurrences. Conclusions Analytical methods for evaluating IVE-based products can be leveraged within the scope of GAC, bringing sustainable work opportunities to analytical development laboratories around the world. Highlights This review shows an overview of the analytical methods present in the literature and official compendiums to evaluate pharmaceutical IVE matrices, in the context of green analytical chemistry.

Buffer system improves the removal of host cell protein impurities in monoclonal antibody purification.

Polysorbates (PS) are commonly used as stabilizers of biopharmaceuticals such as monoclonal antibodies (mAbs). However, they are prone to chemical and enzymatic degradation. The latter can be caused by residual host cell proteins (HCPs) in the drug substance. Degradation affects the functionality of the PS surfactant which can lead to formation of particles. An increasing number of publications describe enzymatic PS degradation. Significant efforts have been made to characterize HCP removal during Downstream Processing (DSP) of mAbs and to develop mitigation strategies. Here we describe the use of glycine buffer for acidic elution in Protein A affinity chromatography compared to acetate buffer, which is more commonly used in the biopharmaceutical industry. Increased turbidity was observed during pH re-adjustment after low pH virus inactivation when using glycine buffer. Analytical data suggests that this turbidity is caused by the formation of precipitates which include HCP and DNA impurities. Additionally, as a zwitterion, glycine does not contribute to conductivity; this further enhances HCP removal during anion-exchange flow-through chromatography. Although glycine is well known as a possible elution buffer for Protein A affinity chromatography, its positive impact on HCP removal and PS stability have not yet been described in literature.

LC-MS Based Quantification of Degradents in Pharmaceutical and Bulk Products of Atazanavir Sulfate and Ritonavir

LC-MS Based Quantification of Degradents in Pharmaceutical and Bulk Products of Atazanavir Sulfate and Ritonavir

From local issue to global challenge: a brief overview of antibiotic shortages since the 1970s

Antibiotic shortages have become a global issue, affecting countries worldwide. These shortages often lead to the overuse of specialized or emergency-reserve antibiotics, which impacts the treatment and increases the risk of drug resistance, making infections harder to treat over time. The COVID-19 pandemic highlighted the severity of these shortages, showing they are neither rare nor isolated but rather common and widespread. This short commentary explores two main questions: firstly, how has antibiotic shortage developed into a serious concern for countries like the United States and Europe, once leaders in antibiotic production; and secondly, how has antibiotic shortage grown from localized and isolated issues into the global concern, affecting countries around the world? By employing historical analysis, this commentary aims to underscore the growing but overlooked issue, pointing to a broad and deeply rooted problem of the pharmaceutical production landscape.

Application of Electrospun Nanofiber-Based Electrochemical Sensors in Food Safety

Food safety significantly impacts public health and social welfare. Recently, issues such as heavy metal ions, drug residues, food additives, and microbial contamination in food have become increasingly prominent. Electrochemical sensing technology, known for its low cost, simplicity, rapid response, high sensitivity, and excellent selectivity, has been crucial in food safety detection. Electrospun nanofibers, with their high specific surface area, superior mechanical properties, and design flexibility, offer new insights and technical platforms for developing electrochemical sensors. This study introduces the fundamental principles, classifications, and detection mechanisms of electrochemical sensors, along with the principles and classifications of electrospinning technology. The applications of electrospun nanofiber-based electrochemical sensors in food safety detection over the past five years are detailed, and the limitations and future research prospects are discussed. Continuous innovation and optimization are expected to make electrospun nanofiber-based electrochemical sensors a key technology in rapid food safety detection, providing valuable references for expanding their application and advancing food safety detection methods.

Genetic optimization of the human gut bacterium Phocaeicola vulgatus for enhanced succinate production

The demand for sustainably produced bulk chemicals is constantly rising. Succinate serves as a fundamental component in various food, chemical, and pharmaceutical products. Succinate can be produced from sustainable raw materials using microbial fermentation and enzyme-based technologies. Bacteroides and Phocaeicola species, widely distributed and prevalent gut commensals, possess enzyme sets for the metabolization of complex plant polysaccharides and synthesize succinate as a fermentative end product. This study employed novel molecular techniques to enhance succinate yields in the natural succinate producer Phocaeicola vulgatus by directing the metabolic carbon flow toward succinate formation. The deletion of the gene encoding the methylmalonyl-CoA mutase (Δmcm, bvu_0309-0310) resulted in a 95% increase in succinate production, as metabolization to propionate was effectively blocked. Furthermore, deletion of genes encoding the lactate dehydrogenase (Δldh, bvu_2499) and the pyruvate:formate lyase (Δpfl, bvu_2880) eliminated the formation of fermentative end products lactate and formate. By overproducing the transketolase (TKT, BVU_2318) in the triple deletion mutant, succinate production increased from 3.9 mmol/g dry weight in the wild type to 10.9 mmol/g dry weight. Overall, succinate yield increased by 180% in the new mutant strain P. vulgatus Δmcm Δldh Δpfl pG106_tkt relative to the parent strain. This approach is a proof of concept, verifying the genetic accessibility of P. vulgatus, and forms the basis for targeted genetic optimization. The increase of efficiency highlights the huge potential of P. vulgatus as a succinate producer with applications in sustainable bioproduction processes.Key points• Deleting methylmalonyl-CoA mutase gene in P. vulgatus doubled succinate production• Triple deletion mutant with transketolase overexpression increased succinate yield by 180%• P. vulgatus shows high potential for sustainable bulk chemical production via genetic optimization

Context‐driven implementation strategies: Exploring three approaches to implement a lean capability framework within a global production company

AbstractThis paper explores global implementation of capability building projects as part of an corporate lean programme. The aim is to identify the core parameters in global implementation of complex knowledge in various contexts within the corporation. The empirical research investigates the global implementation of a lean capability project in three regional clusters within a large pharmaceutical multinational production company. The findings indicate that contextual situations in regional clusters, for example, maturity levels, national culture, and previous experiences, influence the design of the implementation approaches embedding knowledge management principles in various ways. Three types of implementation approaches (horizontal, parallel, and delegated) are identified, which highlights the strategically different pathways to realise new frameworks for knowledge management. This study shows how adjustments to contextual situations influence the implementation process and identifies various hallenges with various approaches that may hinder the execution of lean strategy. This paper puts forward five identified implementation parameters that could guide future research and knowledge management practitioners in opex, HR, and learning and development functions.

A Perspective on the Permeability of Cocrystals/Organic Salts of Oral Drugs.

According to the BCS classification system, the differentiation of drugs is based on two essential parameters of solubility and permeability, meaning the latter is as pivotal as the former in creating marketable pharmaceutical products. Nevertheless, the indispensable role of permeability in pharmaceutical cocrystal profiles has not been sufficiently cherished, which can be most probably attributed to two principal reasons. First, responsibility may be on more user-friendly in vitro measurement procedures for solubility compared to permeability, implying the permeability measurement process seems unexpectedly difficult for researchers, whereas they have a complete understanding of solubility concepts and experiments. Besides, it may be ascribed to the undeniable attraction of introducing new crystal-based structures which mostly leaves the importance of improving the function of existing multicomponents behind. Bringing in new crystalline entities, to rephrase it, researchers have a fairly better chance of achieving high-class publications. Although the Food and Drug Administration (FDA) has provided a golden opportunity for pharmaceutical cocrystals to straightforwardly enter the market by simply considering them as derivatives of the existing active pharmaceutical ingredients, inattention to assessing and scaling up permeability which is intimately linked with solubility has resulted in limited numbers of them in the global pharmaceutical market. Casting a glance at the future, it is apprehended that further development in the field of permeability of pharmaceutical cocrystals and organic salts requires a meticulous perception of achievements to date and potentials to come. Thence, this perspective scrutinizes the pathway of permeation assessment making researchers confront their fear upfront through mapping the simplest way of permeability measurement for multicomponents of oral drugs.

AS ATIVIDADES ANTIOXIDANTES DA PERESKIA ACULEATA MILLER

Ora-pro-nóbis (Pereskia aculeata Miller), a plant native to Brazil, is valued in traditional medicine for its nutritional and therapeutic properties. Recently, scientific interest has grown, particularly due to its antioxidant activities. It is rich in vitamins, iron, and proteins and has shown therapeutic effects such as wound healing and treatment of gastrointestinal diseases. Identified bioactive compounds include phenolic acids, like caffeic acid, and flavonoids, such as quercetin and kaempferol. Studies demonstrate high antioxidant and antimicrobial activity, with effectiveness in inhibiting both Gram-positive and Gram-negative bacteria. The plant's mucilage, known for its water retention capacity, is valuable in the food industry as a thickening and stabilizing agent and also has wound-healing properties, leading to its use in ointments. The biopolymers found, such as arabinogalactans, have potential applications in food and pharmaceutical additives. Ora-pro-nóbis is a rich source of bioactive compounds with potential for new nutraceutical and pharmaceutical products, promoting health and disease prevention.

Cross-contamination Risk Assessment using FMEA tool

In pharmaceutical manufacturing facilities, products with different therapeutic properties and potencies are manufactured in shared spaces, which poses a potential risk for cross-contamination. During the manufacturing process, cross-contamination may occur due to the uncontrolled release of dust, gases/vapors, mix-ups with other materials, residues on equipment, and contamination from operator’s clothing. By implementing adequate facility design and manufacturing operations aligned with Quality Risk Management principles, the risk of cross-contamination can be controlled. If a shared facility is used for manufacturing pharmaceutical products, strategic controls for identifying and managing the risks of cross-contamination should be in place. This article provides a structured and systematic framework for the risk-based identification of the worst-case product and manufacturing process among the products manufactured in the solid oral facility, addressing the high risk of cross-contamination. Keywords: Cross-contamination, Contamination, Risk Assessment, Formal risk assessment, Quality Risk Management (QRM), Failure Mode Effect Analysis (FMEA), Oral Solid Dosage (OSD), Worst case, Contamination Control Strategies (CCS)

A novel approach to simultaneously modulate the processability and thermal performance of phthalonitrile resin through the strategic use of thioether bonds

Phthalonitrile (PN) resin is renowned for its absence of small molecule release during curing, high processing stability, and exceptional thermal stability, positioning it favorably in the realm of high-temperature resin applications. However, its narrow processing window and high melting point present challenges to its development and practical use. To address these limitations, this work synthesized PN prepolymers 4,4′-bis (sulfonylbiphenyl) thiophtalonitrile (BSPS) and 4,4′-bis(carbonylbiphenyl) thiophtalonitrile (BSPC) by introducing thioether bonds as a substitute for ether bonds, aiming to expand the prepolymers' processing window. Meanwhile, building upon the oxidation process of thioether to sulfone observed in pharmaceutical production, the potential for in-situ oxidation of thioether bonds during the curing of phthalonitrile prepolymers was investigated. A comprehensive analysis of the curing behavior, viscosity changes, and thermal stability was conducted using differential scanning calorimetry (DSC), rheological analysis, and thermogravimetric analysis (TGA). The DSC and rheological test results reveal that the experimental group prepolymers BSPS and BSPC exhibit lower melting points (BSPS 179 °C; BSPC 180 °C) and broader processing windows (BSPS 52 °C; BSPC 79 °C) than blank. Additionally, the thermal performance of resins show improvement over the blank, with BSPS achieving a decomposition temperature of up to 530 °C (Td5%). XPS analysis of the curing process confirmed that the enhanced thermal stability is attributable to the partial oxidation of thioether bonds into stable sulfone groups. This innovative structural approach allows for satisfactory processing performance in the initial stage, followed by a spontaneous transformation into a more robust and thermo-resistant structure post-shaping. This finding carries significant implications for the development of a balanced phthalonitrile system that harmonizes processing ease with superior thermal endurance.

Determination of dimethyl sulfate genotoxic impurity in pantoprazole sodium sesquihydrate by derivatization method and UPLC/MS

In this study, a new method has been developed and, the method has been validated to analyze dimethyl sulfate (DMS) which known as a genotoxic impurity. DMS has been detected in trace levels within the drug substance pantoprazole sodium sesquihydrate using the derivatization method. Triethylamine has been used as derivatization reagent. Due to the highly polar nature of the derivatization product, which is a quaternary ammonium ion, a polar retention Hilic column has been used for chromatographic separation. The Waters QDA detector has been used in the single ion recording (SIR) mode at m/z 116 for the detection of the quaternary ammonium ion. In this study, the recovery rates have been achieved within the range of 96.46–105.98%. The LOD has been determined as 1.94E-07 mg/mL, and the LOQ has been determined as 6.46E-07 mg/mL. From the results, it can be said that the improved method in this study, would enables fast and reliable solutions for routine quality control analyses for DMS in API companies that especially is producing PSS.

Critical review on toxic contaminants in surface water ecosystem: sources, monitoring, and its impact on human health.

Surface water pollution is a critical and urgent global issue that demands immediate attention. Surface water plays a crucial role in supporting and sustaining life on the earth, but unfortunately, till now, we have less understanding of its spatial and temporal dynamics of discharge and storage variations at a global level. The contamination of surface water arises from various sources, classified into point and non-point sources. Point sources are specific, identifiable origins of pollution that release pollutants directly into water bodies through pipes or channels, allowing for easier identification and management, e.g., industrial discharges, sewage treatment plants, and landfills. However, non-point sources originate from widespread activities across expansive areas and present challenges due to its diffuse nature and multiple pathways of contamination, e.g., agricultural runoff, urban storm water runoff, and atmospheric deposition. Excessive accumulation of heavy metals, persistent organic pollutants, pesticides, chlorination by-products, pharmaceutical products in surface water through different pathways threatens food quality and safety. As a result, there is an urgent need for developing and designing new tools for identifying and quantifying various environmental contaminants. In this context, chemical and biological sensors emerge as fascinating devices well-suited for various environmental applications. Numerous chemical and biological sensors, encompassing electrochemical, magnetic, microfluidic, and biosensors, have recently been invented by hydrological scientists for the detection of water pollutants. Furthermore, surface water contaminants are monitored through different sensors, proving their harmful effects on human health.

Investigation of the Influence of Copovidone Properties and Hot-Melt Extrusion Process on Level of Impurities, In Vitro Release, and Stability of an Amorphous Solid Dispersion Product.

Hot-melt extrusion (HME) is a widely used method for creating amorphous solid dispersions (ASDs) of poorly soluble drug substances, where the drug is molecularly dispersed in a solid polymer matrix. This study examines the impact of three different copovidone excipients, their reactive impurity levels, HME barrel temperature, and the distribution of colloidal silicon dioxide (SiO2) on impurity levels, stability, and drug release of ASDs and their tablets. Initial peroxide levels were higher in Kollidon VA 64 (KVA64) and Plasdone S630 (PS630) compared to Plasdone S630 Ultra (PS630U), leading to greater oxidative degradation of the drug in fresh ASD tablets. However, stability testing (50 °C, closed container, 50 °C/30% RH, open conditions) showed lower oxidative degradation impurities in ASD tablets prepared at higher barrel temperatures, likely due to greater peroxide degradation. Plasdone S630 is suitable for ASDs with drugs prone to oxidative degradation, while standard purity grades may benefit drugs susceptible to free radical degradation, as they generate fewer free radicals post-HME. ASD tablets exhibited greater physical stability than milled extrudate samples, likely due to reduced exposure to stability conditions within the tablet matrix. Including SiO2 in the extrudate composition resulted in greater physical stability of the ASD system in the tablet; however, it negatively affected chemical stability, promoting greater oxidative degradation and hydroxylation of the drug substance. No impact of the distribution of SiO2 on drug release was observed. The study also confirmed the congruent release of copovidone, the drug substance, and Tween 80 using flow NMR coupled with in-line UV/vis. This research highlights the critical roles of peroxide levels and SiO2 in influencing the dissolution and physical and chemical stability of ASDs. The findings provide valuable insights for developing stable and effective pharmaceutical formulations, emphasizing the importance of controlling reactive impurities and excipient characteristics in ASD products prepared by using HME.

Photoelectrocatalytic allylic C–H oxidation to allylic alcohols coupled with hydrogen evolution

Allylic C–H bond oxidation of cycloolefins to allylic alcohols has attracted tremendous attention owing to its widespread application in pharmaceuticals production and natural synthesis. However, the production of allylic alcohols still suffers from the challenges of unsatisfactory selectivity and harsh conditions. Herein, we report the sustainable photoelectrocatalytic (PEC) allylic C–H oxidation to allylic alcohols, achieving the oxidation of cyclohexene to 2-cyclohexenol with a selectivity of 97.2 %. We reveal the reaction pathway wherein photogenerated holes and OH– synergistically activate cyclohexene to carbocation intermediates, and these intermediates combine with OH– to produce 2-cyclohexenol. Additionally, the mechanism by enriching OH– in local area of photoanode surface to enhance PEC performance is uncovered. Furthermore, we designed a self-powered PEC reaction system, attaining a 2-cyclohexenol productivity of 11.95 μmol h–1 (selectivity > 97 %) coupled with a H2 productivity of 1.44 mL h–1, demonstrating the application potential of this new strategy.

Effect of MHD and radiation on biviscous Bingham fluid flow on Marangoni boundary for heat source/sink with chemical reaction

A significance of Marangoni-driven convective magnetohydrodynamics (MHD) was investigated in a planned study. The present study examines the impact of radiation and chemical reactions on the two dimensional boundary layer flow of bi-viscous Bingham fluid on a thermosolutal Marangoni boundary with magnetic field and heat source/sink. The physical flow problem is mathematically modelled into Navier–Stokes equations. These nonlinear partial differential equations are then mapped into a set of nonlinear ordinary differential equations using similarity transformation. The elegant analytical method is used to obtain analytic approximations for the resulting system of nonlinear differential equations. The analytical solution for the temperature and concentration profiles is expressed in terms of Kummer's confluent hypergeometric function. The features of flow characteristics such as velocity, temperature, and concentration profiles in response to the variations of the emerging parameters are simulated and examined with a physical explanation through graphs. Surface tension is considered to be corresponding to heat and mass. The results reveal that the velocity profile decreases with increasing the magnetic field, while the Marangoni number value increases with increasing the velocity profile. Moreover, the temperature profile rises with rising the radiation parameter and whereas the value chemical reaction parameter upsurges with decline concentration profile. The present problem has great interest due to its applications in industrial applications such as drying of silicon wafers, thin layers of paint, glues, in heat exchangers, crystal growth in space, biological fluids, blood, synovial liquids, plasma, lubricants, many pharmaceutical products, proteins, sewage sludge, china clay, and many more.

Comparison of strength and adulteration between illicit drugs obtained from cryptomarkets versus off-line.

Drugs sold on cryptomarkets are thought to have lower levels of adulteration and higher strength compared with those sourced off-line. The present study aimed to determine whether cryptomarket and off-line-sourced 3,4-methylenedioxy-N-methamphetamine (MDMA), cocaine, amphetamine, methamphetamine and lysergic acid diethylamide (LSD) differed in adulteration and strength. A between-groups design was used to compare cryptomarket versus off-line-sourced drugs. Regression analyses controlling for year and service were conducted. Drug-checking services were conducted in Spain (Energy Control) and the Netherlands (Drugs Information and Monitoring System). The cases comprised drug samples that underwent drug checking between 2016 and 2021 and were expected to contain MDMA (tablets; n = 36 065; powder: n = 6179), cocaine (n = 11 419), amphetamine (n = 6823), methamphetamine (n = 293) and LSD (n = 1817). Drugs were measured for (1) matching the advertised substance (i.e. containing any amount of the expected substance); (2) strength; (3) presence of adulteration; and (4) number of adulterants. The expected drug was more likely to be identified when sourced from cryptomarkets versus off-line for MDMA tablets [adjusted odds ratio (AOR) = 2.10, 95% confidence interval (CI) = 1.28-3.43], MDMA powder (AOR = 2.64, CI = 1.55-4.51), cocaine (AOR = 3.65, CI = 1.98-6.71) and LSD (AOR = 1.75, CI = 1.13-2.72). Cryptomarket-sourced MDMA powder (β = 0.03, P = 0.012), cocaine (β = 0.08, P < 0.001) and methamphetamine (β = 0.15, P = 0.028) were statistically significantly higher in strength than substances from off-line sources. Conversely, MDMA tablets (β = -0.01, P = 0.043) and amphetamine (β = -0.07, P < 0.001) from cryptomarkets were statistically significantly lower in strength than from off-line sources. MDMA powder (AOR = 0.53, CI = 0.33-0.86) and cocaine (AOR = 0.66, CI = 0.55-0.79) were statistically significantly less likely to be adulterated if sourced from cryptomarkets. However, amphetamine (AOR = 1.54, CI = 1.25-1.90) and LSD (AOR = 1.31, CI = 1.00-1.71) were found to be more likely to be adulterated when purchased from cryptomarkets. Cocaine from cryptomarkets exhibited fewer adulterants (incidence rate ratio = 0.71, CI = 0.60-0.85). The relationship between on-line drug market-places and substance quality varies depending on both the specific substance and the dynamics of the cryptomarket.

NDSRIs Crisis in Pharmaceuticals; Insights on Formation Pathways, Root Causes, Risk Management, and Novel Analytical Techniques.

The discovery of a new class of nitrosamine impurities called N-nitroso drug substance related impurities (NDSRIs) in pharmaceuticals has emerged as a significant challenge for the pharmaceutical sector due to their significant genotoxic and mutagenic effects. Regulatory bodies globally in active collaboration with all the concerned stake holders, are taking effective measures to prevent and control NDSRIs. This comprehensive review on NDSRIs discusses formation pathways, root cause analysis, acceptable intake limits, case studies, control strategies and regulatory responses pertaining to recent NDSRI incidents. This review discusses the novel liquid chromatographic techniques (LC- MS/MS, GC-MS/MS) used to identify and quantify of NDSRIs. This review would aid pharmaceutical professionals, R&D analytical and formulation scientists, and regulatory bodies in gaining deeper insights into the NDSRIs crisis, facilitating formulation of NDSRI-free drug products, and ensuring their sensitive detection with accurate risk evaluation.

Surface enhanced transmission Raman spectroscopy: Quantitative performances for impurity analysis in complex matrices

A transmission detection mode was investigated with SERS analyses (SETRS). A comparison between backscattering and transmission detection modes was conducted to demonstrate the feasibility of performing SETRS analyses. The impact of various parameters on the SERS signal intensity such as sample volume, lens collection optic, laser beam size and laser power were then examined. The analytical performances of SETRS were further evaluated through the quantification of an impurity (4-aminophenol) ranging from 3 to 20 µg/mL in a commercial pharmaceutical product using a total error risk-based approach. To account for expected variability of routine analysis, 9 batches of silver nanoparticles suspensions were used and experiments were performed over 5 different days and by 2 operators. Univariate spectral analysis based on a quadratic regression was compared to a multivariate approach using a partial least square regression. The presented results demonstrated that SETRS can be used to determine an impurity in a complex matrix opening new perspectives for quantitative applications.

A Novel High Performance Liquid Chromatography Method for Camphor Determination and Application in Cosmetics and Pharmaceuticals: Development and Validation

A novel high-performance liquid chromatography (HPLC) method with 4-N,N-dimethylaminobenzaldehyde as an internal standard was developed for the determination of Camphor with the main goal of facilitating the analysis of different cosmetic and pharmaceutical products that contain Camphor in analytical laboratories. The method can be applied to cosmetic and pharmaceutical samples such as gels, ointments, and creams containing Camphor. Chromatographic separation was carried out on the Symmetry® C18, 5 μm column (Waters), 250 × 4.6 equipped with guard column E, InertSustain C18, 5 µm, while using the flow of 1.4 mL/min, with a column temperature of 25 °C. The mobile phase consisted of 600 mL of acetonitrile, 400 mL of purified water, and 6 mL of glacial acetic acid. The method was evaluated in accordance with ICH Q2 (R2) guidelines for validation parameters: selectivity, linearity (range 0.10–3.00 mg/mL), the limit of detection (LOD = 0.028 mg/mL), the limit of quantification (LOQ = 0.085 mg/mL), accuracy (confidence intervals &lt; 0.05%), repeatability (peak area ratio = 0.39–1.97), and intermediate precision (peak area ratio = 0.40–1.98). The method is applicable for detecting and quantifying Camphor in a variety of cosmetic and pharmaceutical products from different parts of the world, thus covering the concentrations required by different law legislations.