RESUMO
Objectives: The present study aimed to develop and validate a discriminative dissolution method for tetrahydrocurcumin (THC), a Biopharmaceutical Classification System class II drug, by a simple ultraviolet (UV) spectrophotometric analysis. The final dissolution medium composition was selected based on the solubility and stability criteria of the drug. Materials and Methods: As a prerequisite for this, the solubility of the drug was assessed in media of different pH (1.2-7.4), and surfactant concentrations of 0.5-1.5% (w/v) sodium lauryl sulfate (SLS) in water, and pH 7.4 phosphate buffer. The dissolved drug concentration in each medium was quantified by UV analysis at 280 nm wavelength. Results: The drug solubility was found to be high at a pH of 1.2 and 7.4. The media with surfactant enhanced solubility of the drug by approximately 17-fold and exhibited better sink conditions. The discriminative power of the developed dissolution medium (i.e., 1% w/v SLS in pH 7.4) was determined by performing in vitro dissolution studies of the prepared THC tablets and comparing their release profiles using fit factors (f1 and f2). The results of the fit factor comparisons made between the dissolution profiles of THC tablets proved the discriminative ability of the medium. The validation of the developed dissolution method was performed by international guidelines and the method showed specificity, linearity, accuracy, and precision within the acceptable range. Conclusion: The proposed dissolution method was found to be adequate for the routine quality control analysis of THC, as there is no specified dissolution method for the drug in the pharmacopoeia.
RESUMO
BACKGROUND: Globally, type-2 diabetes mellitus is increasing in epidemic proportions. A major cause of concern in India is the increasing incidence of cases, especially troubling is the observed increase in younger age groups with no risk factors. New evidence suggests that many environmental factors, such as air pollution, persistent organic pollutants (POPs), and environmental estrogens are implicated as risk factors for type-2 diabetes mellitus. Animal and human epidemiological studies have shown ubiquitous lipophilic substances, including POPs, are frequently associated with type-2 diabetes mellitus. Such studies have not been undertaken in Indian youth. METHODS: This is a cross-sectional study that explored the association between POPs and type-2 diabetes mellitus in Indian urban and rural population. About 7 ml of venous blood was collected from all consenting patients and serum was separated immediately and was transported to the lab for further analysis. Serum levels of POPs, including organochlorine (OC) compounds and organophosphorus pesticides, were estimated using sample gas chromatography-mass spectrometry (GC-MS). The fasting blood sugar values and the serum levels of POPS were tested using Pearson correlation coefficient. The magnitude of increase in blood sugar corresponding to increase in POPs was analyzed using linear regression analysis. The odds ratios (ORs) were expressed at 95% confidence intervals (CIs). RESULTS: Three OC pesticides and one organophosphate pesticide were strongly associated with increasing blood sugar levels after adjusting for age, sex, and body mass index - lindane (OR 4.95, 95% CI 1.03-23.73), DDT o, p' (OR 3.50, 95% CI 1.04-11.73), dimethoate (OR 19.31, 95% CI 4.22-88.37), and dichlorvas (OR 6.33, 95% CI 1.28-31.18).
RESUMO
A simple, reproducible and sensitive liquid chromatography (HPLC) method has been developed and validated for estimation of bisphenol A (BPA) in human urine. A simple liquid-liquid extraction technique was used in BPA sample preparation. The analyte was chromatographed on a Shimadzu Prominence HPLC system using isocratic mobile phase conditions at a flow rate of 0.500 ml/min and a Hypersil Gold C18 column maintained at 40°C. Quantification was performed on a fluorescence detector set at excitation 275 nm, emission 313 nm and bisphenol B was used as internal standard. The total run time was 8 min. The method was found to have acceptable sensitivity, selectivity, accuracy (98.82-103.64%), precision (1.17-5.36) and stability in the validation experiment carried out as per the USFDA guidelines. The method sensitivity was as low as 0.50 ng/ml. The applicability of the validated analytical method was established in human patient urine samples. The mean human urine BPA concentrations were 1.18 ± 2.11 ng/ml in the control group and 5.76 ± 6.00 ng/ml in the patient group (P < 0.001). Therefore, this method could be considered as an alternative for routine bio-monitoring of BPA which is less expensive and feasible in resource-poor settings.
