Phase solubility analysis

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PHASE SOLUBILITY ANALYSIS Presented by: K.Bhavya M.Pharmacy (1st year) bhavyakosaraju3@gmail.com

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The amount of substance that passes into solution in order to establish the equilibrium at constant temperature and pressure and so produce a saturate solution is known as the SOLUBILITY of the substance.

SOLUBILITY PROCESS : 

SOLUBILITY PROCESS SOLVENT SOLUTE SOLUTION

ADVANTAGES : 

ADVANTAGES Increased bioavailability Fast absorption Patient compliance No shaking Incorporation of volatile oils, preservatives No gritty particles and smooth are observed

IMPORTANCE OF SOLUBILITY : 

IMPORTANCE OF SOLUBILITY Selection of solvent for dosage form Information about the structure, inter molecular forces. Selection of dissolution medium. Separation of mixtures.

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Separation of optical isomers. Detection of impurities. Preparation of reference substance. Selection of dosage form. Determination of physicochemical properties

PHASE SOLUBILITY ANALYSIS : 

PHASE SOLUBILITY ANALYSIS PSA is the quantitative determination of purity of a substance through the application of precise solubility measurement. Crystalline solids Solid solutions

SOLVENT SELECTION : 

SOLVENT SELECTION Sufficient volatility Boiling point in between 60-150°C Not react with test substance Don't form solvates, salts Pure in nature.

APPARATUS : 

APPARATUS TEMPERATURE BATH Contain horizontal shaft(25rpm) Clam Vibrator(100-120/sec) AMPULE SOLUBILITY FLASK 15ml

STANDARD METHOD : 

STANDARD METHOD Mixing of material with solvent. Establishment of equilibrium. Separation of solid phase from solution. Determination of concentration of material dissolved per unit of solvent. Determination of weight of material unit of solvent. Plotting graph, Extrapolation and calculation.

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Increased amount of sample 5ml solvent Cool in dry acetone Double jet air gas burner Weigh all ampoules SYSTEM COMPOSITION 15 ml 15 ml 15 ml 15 ml 15 ml 15 ml 15 ml 15 ml

EQUILIBRATION : 

EQUILIBRATION Varies with Substance Method of mixing Temperature DETERMINATION OF EQUILIBRATION: Next to last of series Super saturated solution Solubility of test specie 40 c

SOLUTION COMPOSITION : 

SOLUTION COMPOSITION Content settles Ampoule Water bath 2ml Aliquot Solubility flask Dry residue Open ampoule Evaporate vacuum cool

CALCULATIONS : 

CALCULATIONS System composition in mg/gm for each ampoule =1000(w2-w1)/(w3-w2) Solution composition in mg/gm for each ampoule = 1000(F3-F1)/(F2-F3)

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Percentage purity = 100-100s S----graphically or least squares of best fit line A B C D

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BC - Saturate with one component CD - Saturate with 2components AE - Major components EF - Minor components A B C D E F

PURIFICATION TECHNIQUE : 

PURIFICATION TECHNIQUE Test specimen Non reactive solvent seal & shake room temperature,24hr 10% material dissolved Mother liquor Residue , Rince,dry Impurity residue Pure reference

CONCLUSION : 

CONCLUSION Solubility is an important factor in pharmaceutical process. Phase solubility analysis is an important process for Detection of impurities Preparation of reference substance Separation of optical isomers.

REFERENCESS : 

REFERENCESS UNITED STATE PHARMACOPIA <1171> REMINGTON The science and practice of pharmacy Volume 1 page. no 212-214 ESSENTIAL PHYSICAL PHARMACY BY C.V.S Subrahmanyam page. No 55-58 MARTINS Physical pharmacy and pharmaceutical sciences 5th EDITION