Evaluation of precompression parameters

Published: 2020-06-21 05:21:04
1397 words
5 pages
printer Print
essay essay

Category: General Studies

Type of paper: Essay

This essay has been submitted by a student. This is not an example of the work written by our professional essay writers.

Hey! We can write a custom essay for you.

All possible types of assignments. Written by academics

GET MY ESSAY
Evaluation of precompression parametric quantities:
Bulk denseness finding:
Bulk denseness is determined by calibrated cylinder incorporating a known mass of pulverization whose initial volume is noted. cylinder is fixed on the mechanical tapped setup. so the concluding volume is noted, and this majority volume. so bulk denseness is calculated is utilizing
majority denseness = mass of the pulverization ( tungsten ) /bulk voume
Tapped denseness finding:
Weight measure of pulverization was taken in a calibrated cylinder and the volume was measured ( v0 ) . The calibrated cylinder was fixed in the Tapped Densiometer and tapped for 500, 750 and 1250 times untill the difference in the volume after consecutive tapping was less than 2 % . The concluding reading was denoted by ( Vf ) . The volume of blend was used to cipher the tapped denseness, Hausner’s ratio and carr’s index.
Tapped denseness ( TD ) =W/Vf g/ml
Angle of rest:
It is defined as the maximal angle possible between the surface and to the heap of the pulverization and horizontal plane.
Angle of rest and flow belongingss




Angle of rest


Flow belongingss




& lt ; 25


Excellent




25-30


Good




30-40


Passable




& gt ; 40


Very hapless




It was calculated by utilizing the expression given below
angle of rest was calculated by utilizing the expression given below.
Angle of rest ( ? ) = tan-1 ( h/r )
Where, h = tallness of heap
R = radius of the base of the heap
? =angle of rest
carr’s index:
carr’s index is besides known as squeezability. It is finally related to relative flow rate, coherence and atom size. It is simple, fast and popular method of ciphering pulverization flow charecteristics.




& lt ; 10


Excellent




11-15


Good




16-20


Carnival




21-25


passable




26-31


Poor




32-37


Very hapless




& gt ; 38


Very really hapless




Carr’s index was calculated by utilizing the expression
Carr’s Index = ( Tapped Density –Bulk Density ) / Tapped Density x 100
Hausner ratio:
Hausner ratio specifies the flow belongingss of the pulverization and measured by the ratio of tapped denseness to bulk denseness. The relationship between Hauser’s ratio and flow belongings
Table no.18: Hausner ratio and matching flow belongingss




Hausner ratio


flow belongingss




1-1.11


Excellent




1.12-1.18


Good




1.19-1.25


Carnival




1.26-1.34


passable




1.35-1.45


Poor




1.46-1.59


Very hapless




& gt ; 1.6


Very really hapless




Hausner ratio was calculated by utilizing the expression.
Hausner Ratio = Tapped denseness / Bulk denseness
Hausner Ratio = Vf/ V0
Where V0 = Initial volume
Vf = Final volume
Weight fluctuation trial:
This is in process quality control trial to be checked on a regular basis. Any fluctuation in the weight of tablets leads to either under medicine or overdose. So, every tablet in each batch should hold a changeless weight. If needed corrections are made during the compaction of tablets.
Method:Twenty tablets were indiscriminately selected from the entire weight of all tablets mean weight was calculated. The single weights were compared with the mean weight. The % difference in the weight fluctuation should be within the acceptable bounds as per USP.
Thickness:
The thickness of 10 tablets was recorded during the procedure of compaction utilizing vernier calipers.
Hardness:
The opposition of tablet to splintering, scratch or break under status of storage, transit and managing before usage depends upon its hardness. For each preparation, the hardness of 6 tablets was determined utilizing the Schleuniger hardness examiner. This examiner operates in a horizontal place. An anvil driven by an electric motor presses the tablet at a changeless burden rate in contrast to a stationary anvil until the tablet interruptions. A arrow traveling along a scale index provides the Breaking strength value/Hardness value.
Crumbliness:
Crumbliness of the tablets was determined utilizing Roche Friabilator. This trial focuses a figure of tablets to the combined consequence of daze and scratch by using a fictile chamber which revolves at a velocity of 25 revolutions per minute, dropping the tablets to a distance of 6 inches in each revolution. A sample of preweighed 6 tablets was placed in Roche Friabilator which was so operated for 100 revolutions i.e. 4 proceedingss. The tablets were so reweighed. A loss of less than 1 % in weight is by and large measured acceptable.Percentage crumbliness ( % F ) was calculated as follows,
% F = ( Initial weight – Final weight ) / Initial weight ? 100
EZETIMIBE TABLETS DISSOLUTION BY HPLC
Chemical Reagents:
Sodium ethanoate trihydrate: AR class
Sodium lauryl sulphate AR class
Acetic acid: AR class
Ammonium ethanoate: AR class
Acetonitrile: HPLC class
Water: Purified H2O
Preparation OF DILUTE SODIUM HYDROXIDE SOLUTION ;
Weigh and reassign about 2.76g Na dihydrogen phosphate monohydrate into a beaker aontaining 1000ml of H2O and mix. Adjust the pH of the solution to 5.0 ± 0.05 with dilute Na hydrated oxide solution filter the solution through 0.22µm membrane filter.
Preparation OF MOBILE PHASE –A
Use buffer
Preparation OF MOBILE PHASE –B
Use acetonitrile
Preparation OF DILUENT:
Fix a degassed mixture of buffer and methyl alcohol in the ratio of 30:70 % v/v
CHROMATOGRAPHIC CONDITINS:
Column: Kinetex C18, 75 ? 4.6 centimeter, 2.6µ or tantamount
Flow rate: 1.0ml/min
Detection: 230 nanometer
Injectin volume: 10µl
Column temperature: 5?c
Run clip: 10 min
GRADIENT PROGRAME ;




Time ( min )


Mobile stage -A


Mobile stage – Bacillus




0.01


60


40




4.0


40


60




4.5


10


90




6.0


10


90




6.5


60


40




10


60


40




Standard Preparation:
Accurately weigh and reassign about 50 milligrams of ezetimibe working criterion into a 100ml volumetric flask. Add 50 milliliter of dilutant and sonicate to fade out. Dilute to volume with dilutants and mix. Transfer 5.0 milliliter of above solution in to 50 milliliters volumetric flask and dilute to volume with dilutant.
PEPARATION AT SAMPLE SOLUTION:
FOR ASSAY/BLEND ASSAY
Weigh and pulverize non less than accurately weigh & A ; reassign tablet powder/blend tantamount to about 50 milligrams of Ezetimibe in to a 100ml volumetric flask add about 60 milliliters of dilutant & A ; sonicate for non less than 30 proceedingss with intermediate shaking ( keep the sonicator bath temp b/w 200degree Celsiuss to 250degree Celsiuss dilute to volume with dilutant and mix ) .
Centrifuge a part of the solution for 10 min at 500 revolutions per minute filter the solution through 0. 45membrane filter. Discard foremost 3ml of the filtrate.
Transfer 5.0 milliliter of filtered solution into a 50 milliliter volumetric flask and dilute to volume with dilutent & A ; mix.
Procedure:
Individually inject 10of blank.std solution ( 5 times ) & A ; sample solution into chromatographic system record chromatogram & A ; step the extremum responses.
EVELUATION OF SYSTEM SUITBILITY Parameters:
The column efficiency as determined for the Ezetimibe extremum from stdstandard solution is non less than 3000 theoretical platesr & A ; the shadowing factor for the same extremum is non more than 2.0
The % comparative standard divergence of the peak countries obtained from five reproduction injections of standard solution is non more than 2.0
The keeping clip of ezetimibe extremum is at about 3.5 proceedingss.
CALCUATION:
% labelled sum of ezetimibe =
Where
AT =Area of ezetimibe in sample solution
AS = Average country of ezetimibe obtained from 5 replicate injections of standard solution
WS = Weight of ezetimibe working criterion taken in milligram
WT =Weight of sample taken in milligram
P = % Purity of ezetimibe working criterion used
T = Average weight of tablet /blend in milligram
L = Label claim of ezetimibe in milligram
FORMULATION AND EVALUATION OF IMMEDIATE RELEASE TABLETS EZETIMIBE TABLETS
ANALYTICAL METHOD
Table no.19: Standard Calibration Curve of ezetimibe




s.no


Concentration ( µg/ML )


Peak country




1


10


216864




2


20


399655




3


30


346415




4


40


825471




5


50


986066




10
Physical compatibility surveies:
Table no 22: consequences of physical compatibility surveies at different storage conditions




S.NO


Composition inside informations


Initial


Storage conditions/duration




400C, 75 % RH


600C




10 vitamin D


20d


30d


15d


1m




1.


Ezetimibe


An off white crystalline pulverization


complies


complies


complies


complies


complies




2.


Ezetimibe: Lactose monohydrate ( 1: 5 )


White to murder white pulverization


complies


complies


complies


complies


complies




3.


Ezetimibe: MCC ( 1: 1 )


White to murder white pulverization


complies


complies


complies


complies


complies




4.


Ezetimibe: CCS ( 1: 1 )


White to murder white pulverization


complies


complies


complies


complies


complies




5.


Ezetimibe: SLS ( 1: 0.25 )


White to murder white pulverization


complies


complies


complies


complies


complies




6.


Ezetimibe: colloidal Si dioxide ( 1: 0.25 )


White to murder white pulverization


complies


complies


complies


complies


complies




7.


Ezetimibe: HPMC ( 1: 0.25 )


White to murder white pulverization


complies


complies


complies


complies


complies




8.


Ezetimibe: Mg sterate


White to murder white pulverization


complies


coplies


complies


complies


complies














CHEMICAL COMPATABILITY STUDIES:
Table no: Chemical compatability surveies at initial




S.NO


INITIAL SAMPLES


Name OF THE IMPURITIES




H-EZM RCO1


H-EZM RCO2


H-EZM RCO3


H-EZM RCO4


Highest unknown drosss


Entire drosss




1


Ezetimibe


0.000


0.120


0.000


0.000


0.087


0.259




2


Ezetimibe: Lactose monohydrate


0.000


0.114


0.000


0.000


0.088


0.258




3


Ezetimibe: MCC


0.000


0.114


0.000


0.000


0.084


0.249




4


Ezetimibe: Milliliter


0.000


0.118


0.000


0.000


0.088


0.257




5


Ezetimibe: Sodium lauryl sulphate


0.000


0.127


0.000


0.000


0.089


0.268




6


Ezetimibe: colloidal Si dioxide


0.000


0.115


0.000


0.000


0.084


0.251




7


Ezetimibe: HPMC


0.000


0.116


0.000


0.000


0.086


0.256




8


Ezetimibe: Mg sterate


0.000


0.136


0.000


0.000


0.088


0276


















S.NO


INITIAL SAMPLES


Name OF THE IMPURITIES




H-EZM RCO1


H-EZM RCO2


H-EZM RCO3


H-EZM RCO4


Highest unknown drosss


Entire drosss




1


Ezetimibe


0.000


0.121


0.000


0.000


0.088


0.261




2


Ezetimibe: Lactose monohydrate


0.000


0.121


0.000


0.000


0.088


0.267




3


Ezetimibe: MCC


0.000


0.115


0.000


0.000


0.084


0.253




4


Ezetimibe: Milliliter


0.000


0.121


0.000


0.000


0.090


0.267




5


Ezetimibe: Sodium lauryl sulphate


0.000


0.154


0.000


0.000


0.089


0.304




6


Ezetimibe: colloidal Si dioxide


0.000


0.124


0.000


0.000


0.089


0.267




7


Ezetimibe: HPMC


0.000


0.119


0.000


0.000


0.087


0.266




8


Ezetimibe: Mg sterate


0.000


0.143


0.000


0.000


0.089


0.292















Table no: Chemical compatibility surveies at 600storage conditions




S.NO


INITIAL SAMPLES


Name OF THE IMPURITIES




H-EZM RCO1


H-EZM RCO2


H-EZM RCO3


H-EZM RCO4


Highest unknown drosss


Entire drosss




1


Ezetimibe


0.000


0.0197


0.000


0.000


0.088


0.350




2


Ezetimibe: Lactose monohydrate


0.000


0.126


0.000


0.000


0.090


0.287




3


Ezetimibe: MCC


0.000


0.127


0.000


0.000


0.084


0.277




4


Ezetimibe: Milliliter


0.000


0.124


0.000


0.000


0.090


0.284




5


Ezetimibe: Sodium lauryl sulphate


0.000


1.650


0.000


0.000


0.422


0.298




6


Ezetimibe: colloidal Si dioxide


0.000


0.144


0.000


0.000


0.089


0.298




7


Ezetimibe: HPMC


0.000


0.124


0.000


0.000


0.086


0.273




8


Ezetimibe: Mg sterate


0.000


0.154


0.000


0.000


0.088


0.311














H-EZM RC01 –( 2R,5S ) -2- ( 4-hydroxy benzyl ) -N-5-bis ( 4-fiuro phenyl ) -5-hydroxy pentamide.
H-EZM RC02 –( 3R,4S ) -1- ( 4-fluro phenyl ) -3- [ – ( 4-fiuro phenyl ) -3- ( s ) -hydroxy propyl ] -4- ( 4-benzyl oxyphenyl ) -2-azetidinone.
H-EZM RC03 –( 3R,4S ) -4- [ 4- ( benzyloxy ) phenyl ] -1- ( flro phenyl ) -3- [ 3- ( 4-fluro phenyl ) -3-oxo propyl ] azetidine-2-one.
H-EZM RCO5 –( 2R,3R,6S ) -N,6-bis ( 4-fluro phenyl ) -tetrahydro-2- ( 4-hydroxy phenyl ) -2H-pyran-3-carboxamide.
Compound name: ezetimibe




TITILE


SAMPLE NAME


RET.TIME


Area


THEORETICAL Home plates


Shadowing Factor




1


Standard


3.700


1233582


6591


1.1




2


Standard


3.699


1234339


6540


1.2




3


Standard


3.725


1229203


6023


1.2




4


Standard


3.707


1234825


6319


1.2




5


Standard


3.698


1237046


6385


1.2




Average



3.706


1233799


6372


1.2




% RSD



0.30


0.23


3.51


2.15




Compound name: ezetimibe




TITILE


SAMPLE NAME


RET.TIME


Area


Shadowing Factor




1


Sample


3.692


125847


1.2




2


Sample


3.697


1224905


1.2




3


Sample


3.686


1223977


1.2




4


Sample


3.684


1224926


1.2




Average



3.690


1224914


1.2




% RSD



0.16


0.06


0.26

Warning! This essay is not original. Get 100% unique essay within 45 seconds!

GET UNIQUE ESSAY

We can write your paper just for 11.99$

i want to copy...

This essay has been submitted by a student and contain not unique content

People also read