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Title:To carry out in vitro dissolution test in a provided tablet dosage form(immediate release type ).
Theory:
The tablet/capsule disintegration test offers no assurance that the resultant particles will release the drug in the solution at an appropriate rate. For this reason, in vitro dissolution tests and test specification have now been developed for nearly all tablet/capsule products. If attainment of high blood levels for the drug is a product objective, obtaining rapid drug dissolution from the tablet/capsule is usually a critical important. Hence, the rate of dissolution may be directly related to the efficacy of the tablet product, as well as to bioavailability differences between the formulations. As with any in vitro test it is critically important that the dissolution test be correlated with in vivo bioavalability test. Objectives in the development of in vitro dissolution tests are :1) that the release of the drug from the tablet is as close as possible to 100%, 2)that the rate of drug release is uniform batch to batch and is the same as the release rate from those batches proven to be bioavailable and clinically effective. Dissolution of a drug particle depends on several physicochemical properties, including chemical form, crystal habit, particle size, solubility , surface area and wetting properties. The dissolution rate of a drug substance in which surface area is maintained constant during dissolution is described by the modified Noyes-Whitney equation: dC/dt= DA (Cs - C) hV where D is the diffusion coefficient, h is the thickness of the diffusion layer at the solid -liquid interface, A is the surface area of drug exposed to the dissolution me dia, V is the volume of media, Cs is the concentration of a saturated solution of the solute in the dissolution medium at the experimental temperature, and C is the concentration of drug in the solution at time t. dC/dt is the dissolution rate. Dissolution test is designed to determine the compliance with the dissolution requirements for solid dosage forms (capsule/tablet) administered orally. Two types of apparatus are prescribed for the dissolution test of capsule/tablet. All parts of the apparatus that may come into contact with the preparation under examination or with the dissolution medium are chemically inert and do not adsorb, react or interfere with the preparation under examination. All parts of the apparatus that may come into contact with the preparation or the dissolution medium must be made from stainless steel.type 316 or equivalent or coated with a suitable material to ensure that such parts do not react or interfere with the preparation under examination or the dissolution medium. An assembly consisting of the following: a. A cylindrical vessel , made of borosilicate glass or any other suitable transparent material, with a hemispherical bottom and with a nominal capacity of l000ml and an inside diameter of 98-106mm.The vessel has a flanged upper rim and is fitted with a lid that has a number of openings, one of which is central.

b. A motor with a speed regulator capable of maintaining the speed of rotation of the paddle or detachable basket within 4 per cent of that specified in the individual monograph. The motor is fitted with a stirring element which consists of a drive shaft and blade forming a paddle/or basket.

c. A water-bath set to maintain the dissolution medium at 36.5C to 37.5C. The bath liquid is kept in constant and smooth motion during the test. The vessel is securely clamped in the water-bath in such a way that the displacement vibration from other equipment, including the water circulation device is minimized. Acceptance table Level S1 S2 S3

Number tested 6 6 12

Acceptance criteria Each unit is not less than Q+5 per cent Average of 12units(S1+S2) is equal to or greater Q and no unit is less than(Q-15) per cent Average of 24 units(S1+S2+S3) is equal to or greater than Q, not more than 2 units are less than Q-15 per cent, and no unit is less than Q-25 per cent.

Chemicals required:
1)Metronidazole tablets, 2)Hydrochloric acid(0.1M).

Apparatus required:
1)Dissolution test apparatus(Six-buckets), 2)Volumetric flasks, 3)Funnels, 4)Pipettes, 5)Beakers, 6)Filter papers, 7)Double beam UV/Vis spectrophotometer.

Procedure:
Apparatus: No 1 Medium: 900 ml of 0.1 M hydrochloric acid. Speed and time: l00 rpm and 60 minutes. Place the stated volume of the dissolution medium into the vessel(bucket) of the apparatus. Assemble the apparatus and warm the dissolution medium to 36.5C to 37.5C. Place one dosage unit in each apparatus. When Apparatus- 1

is used, allow the tablet or capsule to sink to the bottom of the vessel prior to the rotation of the paddle. Then start the rotation of paddles. Then after the stated time withdraw a suitable volume of the medium(Do not agitate the medium) and filter promptly through a filter paper. Reject the first few ml of the filtrate. Sample solution preparation: Dilute 2ml of the filtrate to 100ml with the same solvent(0.1M hydrochloric acid). Standard solution preparation: Weigh accurately about 0.0500g of metronidazole W.S then transfer quantitatively into a 250ml volumetric flask. Shake to dissolve with hydrochloric acid(0.1M) and dilute to the mark with the same solvent. Pipet 5ml of the solution into a 100ml volumetric flask and dilute to the mark with same solvent(10g/ml). Measure the absorbance of the resulting solutions(Std./Sp.) at the maximum at about 277 nm against the solvent blank . Calculate the content of C6H9N3O3 by comparing the absorbance of the sample solution with that of standard/reference solution. Not less than85(Q) per cent of the stated amount of metronidazole(C6H9N3O3).

Observations:
Tablets Absorbance 1 2 3 4 5 6

Calculation:
Dissolution of metronidazole from Tablet-1:

Dissolution of metronidazole from Tablet-2:

Dissolution of metronidazole from Tablet-3:

Dissolution of metronidazole from Tablet-4:

Dissolution of metronidazole from Tablet-5:

Dissolution of metronidazole from Tablet-6:

Results(state the percentage dissolution of metronidazole from each tablet with respect to the stated amount):