LANSOPRAZOLE SOP


1.0  OBJECTIVE:
To lay down a procedure for the active raw material of the Lansoprazole from the Pharmacopoeial specifications.
2.0  SCOPE:
This SOP shall be applicable in Q.C laboratory.
3.0  RESPONSIBILITY:
3.1  Q.C Analyst.
4.0  ACCOUNTABILITY:
4.1  Q.C Manager.
5.0  PROCEDURE:
5.1  Characters:
5.1.1        Appearance:
5.1.1.1  White or brownish powder.
5.1.2        Solubility:
5.1.2.1  Material and equipment:
5.1.2.1.1        Glassware (3 test tubes, 1 spatula).
5.1.2.1.2        Anhydrous ethanol.
5.1.2.1.3        Acetonitrile.
5.1.2.1.4        Purified water.
5.1.2.2  Sample:
5.1.2.2.1        Small quantity.
5.1.2.3  Method:
5.1.2.3.1        Take 3 test tubes and add small quantity of sample for testing solubility according to B.P specifications.
5.1.2.3.2        Add purified water in test tube 1 and observe.
5.1.2.3.3        Add Anhydrous ethanol in test tube 2 and observe
5.1.2.3.4        Add Acetonitrile in test tube 3 and observe.
5.1.2.4  Observations:
5.1.2.4.1        The sample in test tube 1 containing with purified water is very practically insoluble.
5.1.2.4.2        The sample in test tube 2 containing with anhydrous ethanol is soluble.
5.1.2.4.3        The sample in test tube 3 containing with Acetonitrile is slightly soluble.
5.2  Assay:
5.2.1        Apparatus:
5.2.1.1  Glassware (according to requirement).
5.2.1.2  Potentiometer.
5.2.1.3  Magnetic stirrer.
5.2.2        Material and reagents:
5.2.2.1  40.0ml of ethanol (96%).
5.2.2.2  0.1M sodium hydroxide.
5.2.2.3  Thymolphthalein solution (as indicator).
5.2.2.4  Purified water.
5.2.3        Sample:
5.2.3.1  0.300g.
5.2.4        Method of analysis:
5.2.4.1  Take a 100.0ml of beaker and take 0.300g of sample in it.
5.2.4.2  And add 40.0ml of ethanol (96%) dissolve it by using magnetic stirrer operate according to SOP.
5.2.4.3  Dilute it to 50.0ml with purified water.
5.2.4.4  Fill the right hand side burette with titrant 0.1M sodium hydroxide.
5.2.4.5  Carry out a Potentiometric titration using thymolphthalein solution (as indicator).
5.2.4.6  Operate potentiometer according to SOP.
5.2.4.7  To neutralize analyte add titrant fixed volume (1ml, 0.5ml or 0.1ml) from burette every time note the reading of change in potential difference (millivolts) for each addition in given annexure-1.
5.2.4.8  Plot a graph, volume used v/s millivolts.
5.2.4.9  Find out the END POINT.
5.2.4.10    Peak of graph indicates END POINT i.e. the point at which maximum millivolts. Note down volume used at that point.
5.2.4.11    Perform blank titration without using sample. Similarly, as sample titration performed. Record observations in annexure-1.
5.2.4.12    Calculate volume used by substance by using formula:
Volume used by substance = Blank titration - Sample titration.
5.2.4.13    Calculate percentage purity of the sample by using formula:
%age purity = volume used by substance x factor x 100
                             Weight of sample
5.2.5        Factor:
5.2.5.1  1ml of 0.1M sodium hydroxide is equivalent to 36.94mg of Lansoprazole C16H14F3N3O2S.
5.2.6        Limit:
5.2.6.1  99.0% to 101.0% (dried substance).
6.0  REVISION LOG:
Revision No.
Effective Date
Reason
00

New SOP

7.0  REFERENCES:
7.1  The British Pharmacopoeia. Vol II., Official Monograph / Lansoprazole: 2015, pp. 77-78.
8.0  ANNEXURES:
Annexure 1: Assay observations and calculations (Potentiometric titration).




Annexure: 1
Assay observations and calculations (Potentiometric titration)
Potentiometric titration
Reference electrode: ___________________
Indicator electrode: ____________________
Speed of magnetic stirrer: _______________
Titrant used: __________________________
Indicator: ____________________________
Blank titration:
Sr.#
Volume used
(ml)
Voltmeter
(mV)












Plot a graph, volume used v/s millivolts and find out peak of graph i.e. END POINT of blank titration.
Sample titration:
Sr.#
Volume used
(ml)
Voltmeter
(mV)












Plot a graph, volume used v/s millivolts and find out peak of graph i.e. END POINT of sample titration:
Volume used by Blank titration: __________________
Volume used by Sample titration: _________________
Volume used by substance = Blank titration - Sample titration.




mV used by Blank titration: __________________
mV used by Sample titration: _________________
mV used by substance = Blank titration - Sample titration.






Volume used by substance: _______________________
Voltmeter (mV) used by substance: _________________





RESULT: ____________________________________________________________






9.0  ABBREVIATIONS:
Abbreviation
Expanded Form
SOP
Standard operating procedure
&
And
No.
Number  
Ltd.
Limited
QCA
Quality control active ingredient
F
Format
Q.C
Quality control
Vol
Volume
v/s
Verses
Mv
Millivolts
G
Grams
ml
Milliliter
oC
Degree centigrade
mg
Milligram
M
Molar
%
Percentage
R
Reagent


No comments:

Post a Comment