The density (q), viscosity (g) and ultrasonic speed (U) of the pure solvents: 1,4-dioxane (DO), ethyl acetate (EA), tetrahydrofuran (THF) and solutions of the biologically active 1,1 0 -bis(3-methyl-4-ethoxyacetylphenoxy)cyclohexane were investigated at four temperatures: 298, 303, 308 and 313 K over a wide range of concentrations (0.1-0.01 molÁdm -3 ) to understand molecular interactions in these solutions. Various acoustical and thermodynamic parameters such as specific acoustical impedance (Z), isentropic (adiabatic) compressibility (j S ), Rao's molar sound function (R m ), van der Waals constant (b), internal pressure (p), free volume (V f ), intermolecular free path length (L f ), classical absorption coefficient {(a/f 2 ) Cl }, viscous relaxation time (s), Gibbs energy of activation (DG*), enthalpy of activation (DH*) and entropy of activation (DS*) were determined using the q, g and U data. A good to excellent correlation between a given parameter and concentration (C) is observed at all temperatures (T) and solvent systems studied. A linear increase or decrease of acoustical and thermodynamic parameters with concentration and temperature indicate the presence of strong molecular interactions in the solutions. DG* decreases linearly with increasing concentration and temperature in the DO system, while it decreases with C and increases with temperature in the EA and THF systems. The enthalpy of activation (DH*) was found to be practically independent of concentration but DH* and DS* were found to be slightly concentration dependent. In the DO system they are positive, while in the EA and THF systems they are negative.
Density (ρ), viscosity (η), ultrasonic speed (U), and thermo-acoustical parameters such as specific acoustical impedance (Z), adiabatic compressibility ( a ), internal pressure (π), free volume (V f ), inter molecular free path length (L f ), Van der Waals constant (b), viscous relaxation time (), classical absorption coefficient (α/f 2 ) cl , Rao's molar sound function (R m ), solvation number (S n ), Gibbs free energy of activation (ΔG*), enthalpy of activation (ΔH*) and entropy of activation (ΔS*) of biologically active 1,1'-bis(3-methyl-4-carboxyethylphenoxy)cyclohexane (BMCPC) in 1,4-dioxane (DO), ethyl acetate (EA), tetrahydrofuran (THF) have been studied at four different temperatures: 298, 303, 308 and 313 K to understand the molecular interactions in the solutions. A good to excellent correlation between a given parameter and concentration is observed at all temperatures and solvent systems studied. Linear increase or decrease [except (α/f 2 ) cl ] of acoustical parameters with concentration and temperature indicated the existence of strong molecular interactions. ΔG* decreased linearly with increasing concentration and temperature in DO and EA systems and increased with temperature in THF system. ΔH* and ΔS* are found practically concentration independent in case of DO and EA system but both are found concentration dependent in THF system
Objective:
A simple, sensitive, and accurate in-vitro dissolution method has been developed for Olmesartan Medoxomil (OLM), Chlorthalidone (CHLR) & Cilnidipine (CIL) drug combination according to USP dissolution testing methodologies with different discriminating mediums and validated as per ICH guidelines.
Methods:
The in-vitro dissolution profile was obtained using 900 ml of phosphate buffer pH 6.8 with 1.0% SLS at 37 °C ± 0.5 °C as dissolution medium and USP II (paddle) at 75 rpm. The average % in-vitro drug release was above 80% within 45 minutes for the above drug combination. The drug release profile was evaluated by RP-HPLC method. Chromatographic separation was done on Hypersil-BDS C-18 (12.5cm x 4.6mm x 5µm) column using gradient program with initial mobile phase ratio of 55:45 (v/v) mixture of ammonium acetate buffer (pH 5.0) and acetonitrile at a flow rate of 1.0 ml/min with detection wavelength 260 nm.
Results:
The method was validated with respect to specificity, linearity, precision, accuracy, and robustness. The method was found to be linear in the range of 7.0-21.0 μg/ml for CHLR (R2 = 0.9982), 22.5-67.5 μg/ml for OLM (R2 = 0.9999) and 5.5 -16.5 μg/ml for CIL (R2 = 0.9995) respectively. The % recovery data were found between 98.3 % to 104.1%. The % RSD for method and intermediate precision of method did not exceed more than 2%.
Conclusion:
The proposed in-vitro method can be applied successfully for routine quality control analysis to check the quality of above drug combination.
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