Two methods for the simultaneous determination of Emtricitabine and Tenofovir by spectroscopy have been developed. These two simple, accurate and precise methods include Area Under the Curve (AUC) method and Dual Wavelength Method. From a solvent effect studies and the spectral behaviours of Emtricitabine and Tenofovir, methanol was selected as solvent. Emtricitabine shows maximum absorbance at 281 nm and Tenofovir shows maximum absorbance at 259 nm. For the AUC method, the wavelength ranges between 242-248 nm and 269-275 nm were selected with reference to the absorbance curves plotted between the wavelengths of 200-400 nm. In the second method i.e. Dual method in which two wavelengths were selected for each drug in a way so that the difference in absorbance is zero for another drug. Emtricitabine shows equal absorbance at 230.696 nm and 250 nm, where the differences in absorbance were measured for the determination of Tenofovir. Similarly, differences in absorbances at 250 nm and 268.670 nm were measured for determination of Emtricitabine. These methods allows rapid analysis of two drug combination. The results of analysis were validated statistically and by recovery studies. This tablet containing both drugs was assayed using the methods developed, showing a good accuracy and precision.
BackgroundOjamin (OJ), a polyherbal antidiabetic formulation, is extensively used as a food supplement to control diabetes alone or along with synthetic antidiabetic agents. However, it's phytochemical and pharmacological investigations are lacking.ObjectiveThe present study was undertaken to study antidiabetic and antihyperlipidemic potentials of OJ and its interaction with Metformin in streptozotocin (STZ)-induced diabetic rats.Materials and methodsDiabetes was induced in Wistar rats by single intraperitoneal (i.p.) injection of streptozotocin (60 mg/kg). Antidiabetic, antihyperlipidemic activities of OJ were evaluated at dose of 0.28 ml/kg by estimating biochemical changes in urine, serum and liver tissue homogenate and histological changes in liver and pancreatic tissues. Metformin (100 mg/kg, p.o.) was used as reference standard drug.ResultsResults indicate that STZ administration caused hyperglycemia, increased serum glycosylated hemoglobin content, altered serum lipid profile, polyuria, decreased liver glycogen content and histological changes in liver and pancreatic tissues. This elevated serum glucose level and urine volume was significantly decreased by OJ. Supplementation with OJ produced significant improvement in serum lipid profile and glycosylated hemoglobin content along with significant increase in the liver glycogen content. OJ treatment also restored histological changes in liver and pancreatic tissue near to the normal. The observed antidiabetic and hypolipidemic effects of OJ were superior to Metformin. Co-treatment of diabetic rats with OJ and Metformin failed to control blood glucose levels.ConclusionIt is concluded that the OJ possesses significant antidiabetic and antihyperlipidemic activities in rats. However, co-administration of OJ and Metformin is cautioned.
Three simple, economical, precise, and accurate methods are described for the simultaneous determination of Tenofovir disoproxil fumarate (TE) and Emtricitabine (EM) in combined tablet dosage form. The first method is ratio derivative spectra, second is first-order derivative spectrophotometry and third is absorption corrected method. The amplitudes at 271.07 and 302.17 nm in the ratio derivative method, 224.38 and 306.88 nm in the first order derivative method were selected to determine Tenofovir disoproxil fumarate (TE) and Emtricitabine (EM), respectively, in combined formulation. Beer's law is obeyed in the concentration range of 3-21 μg/ml for TE and 2-14 μg/ml for EM for first two methods and range for third method was 6-30 μg/ml of TE and 4-20 μg/ml of EM. The percent assay for commercial formulation was found to be in the range 98.91%–101.72% for both the analytes by the proposed three methods. Absorption corrected method was successfully applied to carry out dissolution study of commercial tablet formulation by using USP II dissolution test apparatus. The methods were validated with respect to linearity, precision, and accuracy. Recoveries by proposed methods were found in the range of 99.06 %-101.34 % for both the analytes.
A simple, rapid and precise reversed-phase liquid chromatographic method is developed for simultaneous determination of Atorvastatin, Ezetimibe and Fenofibrate in their ternary mixture of commercial pharmaceutical preparations. This method, reported first time for a ternary mixture, uses a Kromasil C18, 250 × 4.6 mm, 5µm analytical column. Analytes were estimated by gradient elution with methanol/water at flow rate of 0.9 mL/min; the column temperature is 40°C and detector wavelength is 240 nm. The sample concentrations are measured on weight basis to avoid the internal standard. The method is validated and shown to be linear. The correlation coefficients for Atorvastatin, Ezetimibe and Fenofibrate are 0.9995, 0.9993 and 0.9996, respectively. The recovery values for Atorvastatin, Ezetimibe and Fenofibrate ranged from 99.7-101. 1%, 99.8-101.3% and 99.7-101.7%, respectively. The relative standard deviation for six replicates is always less than 2%. This HPLC method is successfully applied to the simultaneous quantitative analysis of the title drugs in tablets.
Factorial design tool applied for development of isocratic reversed-phase stability-indicating HPLC method for the analysis of mycophenolate mofetil (MMF) and its degradation products. MMF stress degradation products mycophenolate acid (MPA) and DP3 (USP impurity H) were isolated and used for quantitation. Separation achieved on a Symmetry C18 (250 mm × 4.6 mm, 5.0 ) column using a methanol: acetate buffer (75 : 25 v/v), pH 6.0 (adjusted with acetic acid), at 0.5 mL flow rate, column maintained at 55 ∘ C, and data integrated at 251 nm. MMF is subjected to hydrolysis, oxidation, heat degradation, and so forth; under all these conditions degraded products are well separated. The method validation characteristics included accuracy, precision, linearity, range, specificity, and sensitivity. Robustness testing is conducted to evaluate the effect of minor changes to the chromatographic conditions and to establish appropriate system suitability parameters. The proposed method is used to investigate kinetics of acid, alkali hydrolysis and oxidation process. Major degradation products MPA and DP3 were isolated and quantitated. Characterization of MPA by NMR and LC-MS/MS and other degraded products by LC-MS/MS is attempted successfully. The method is used successfully for the quality assessment of three MMF drug commercial formations and its acid, alkali, and oxidative degradation kinetics study.
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