Vitamin E Assay (By HPLC) Finished Product | Test Procedure | Method of analysis (MOA) |

Vitamin E (Finished product) Assay (By HPLC) 

Standard Preparation: Take 10 mg of vitamin E WS in 100 ml volumetric flask, add diluent to dissolve, and make up volume upto the mark with diluent.

 

Sample Preparation: Weigh sample equivalent to 6.8 IU 100 ml volumetric flask, add 70 ml of diluents and sonicate for 30 minutes, and make up volume upto mark with diluent, shake well and filter.

 

Mobile phase: Methanol : Water  ( 98 : 2 )  

 

Chromatographic Conditions:

Column                         - C₁₅ l = 15 cm, Ǿ = 3.9 mm

Detector wavelength - 254 nm  

Flow rate                      - 1.0 ml / Minute

Injection                       - 200 μl

Diluent : Methanol

Procedure : Inject one blank , five replicate injection of  Standard solution, two replicate injection of sample solution & two bracketing standard solution.

System Suitability:

1) RSD of five replicate injection of  standard solution should not be more than 2.0%

2) RSD of five replicate injection of standard solution and two bracketing standard solution should not be more than 5.0%

3) Tailing factor should not be more than 2.0

Calculation :

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Albendazole (Finished product) Assay (By HPLC) | Finished Product | Test Procedure | Method of analysis (MOA) |

Albendazole (Finished product) Assay (By HPLC)

 

Chromatographic Condition

Principle           - HPLC with UV detector

Column             -  C18 ( 150 x 3.9 mm) 5µ or equivalent

Detection          - UV 235 nm

Flow rate           - 2.0 ml/min.

Injection volume -20 µl

Run Time               - 6 Minutes

Retention Time     - About 3 Minutes

Diluent              - 990 ml methanol + 10 ml Concentrated HCL

Mobile Phase   - Buffer : Methanol ( 400 : 600 ) 

Buffer Preparation - Dissolve 7.35 gm of Disodium phosphate dodecahydtrate (Na₂HPO₄,12 H₂O, Sodium phosphate dibasic) in 400 ml of water (If pH of the mobile phase is greater than 8.0, then adjust to 7.5 with dilute phosphoric acid)

 

Standard Preparation

Weigh accurately about 50 mg Albendazole WS in a 100 ml volumetric flask. Dissolve in diluent and dilute to 100 ml with diluent. Take 1 ml of the above and dilute to 20 ml with mobile phase.

 

Sample Preparation

Weigh accurately a quantity of the powder equivalent to about 50 mg of Albendazole in 100 ml volumetric flask add diluent upto mark and keep stirring for 30 minutes then sonicate for 10 min. Then shake and filter. Take 1 ml of the filtrate and dilute to 20 ml with mobile phase.

 

Procedure: Inject one blank, five replicate injection of standard solution, two replicate injection of sample solution & two bracketing standard solution.

 

 System Suitability:

 1) RSD of five replicate injection of standard solution should not be more than 2.0%

 2) RSD of five replicate injection of standard solution and two bracketing standard solution should not be more than 5.0%

 3) Tailing factor should not be more than 2.0

 

Calculation :                                     

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Isometamidium chloride hydrochloride (Finished product) Assay (By HPLC) | Finished Product | Test Procedure | Method of analysis (MOA) |

Isometamidium chloride hydrochloride (Finished product) Assay (By HPLC)

Chromatographic condition:

Column                    - C8 (125 x 4.5 mm) 5µ or equivalent

Flow Rate                 - 1.0 ml / minute.

Wavelength              - 320 nm

Injection Volume      - 20 µl

 

Peak Number	Retention Time	Relative Retention Time
I	3.8	0.6
II	5.5	0.87
III	6.3	1
IV	7.5	1.17
V	15.9	2.52

 

Mobile Phase - Buffer: Acetonitrile (77:23)

Buffer Preparation: Dissolve 2.7 g of Potassium Dihydrogen Phosphate in 950ml distil water. Adjust pH to 2.5 with orthophosphoric acid and dilute to 1000 ml with distilled water.

Standard Preparation

Take 100 mg of Isometamidium chloride hydrochloride WS in 100 ml volumetric flask and dilute to 100 ml with 30 % v/v solution of Acetonitrile in water. Stir for 15 minutes on magnetic stirrer to dissolve it completely.

Sample Preparation

Take sample equivalent to 100 mg of Isometamidium chloride hydrochloride in 100 ml volumetric flask and dilute to 100 ml with 30% v/v solution of Acetonitrile in water.  Stir for 15 minutes on magnetic stirrer to dissolve it completely.

 

Procedure: Inject one blank, five replicate injection of standard solution, two replicate injection of sample solution & two bracketing standard solution.

 

 System Suitability:

 1) RSD of five replicate injection of standard solution should not be more than 2.0%

 2) RSD of five replicate injection of standard solution and two bracketing standard solution should not be more than 2.0%

 

Calculation

Content of Isometamidium chloride hydrochloride in mg/ 

 

     Mean peak area of the Spl (sp1+sp2+sp3+sp4+sp5) x weight

     of std. taken x100 x  Std. Purity of WS x av. Net content

= -------------------------------------------------------------------------------

   Mean peak area of standard (std1+std2+std3+std4+std5)

     x 100 x weight of sample taken x100

 

% of Isometamidium chloride hydrochloride

   Isometamidium chloride hydrochloride in mg

 =---------------------------------------------------------------x 100

                                 Label claim    

 

Where,

sp1 = Area of sample peak I

sp2 = Area of sample peak II

sp3 = Area of sample peak III

sp4 = Area of sample peak IV

sp5 = Area of sample peak V

std1 = Area of standard peak I

std2 = Area of standard peak II

std3 = Area of standard peak III

std4 = Area of standard peak IV

std5 = Area of standard peak V

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SOP for Entry And Exit from Quality Control department. (Standard Operating Procedure)

1.0	OBJECTIVE :
	To provide a Procedure For Entry And Exit from Quality Control department.
2.0	SCOPE :
	This procedure is applicable for entry and exit to Quality Control department at XYZ
3.0	RESPONSIBILITY :
	All  Employee of the Department
4.0	ACCOUNTABILITY:
	Quality Control Head
5.0	PROCEDURE :
	5.1	ENTRY IN QUALITY CONTROL DEPARTMENT
		5.1.1	Collect the set of uniform from linen counter.
		5.1.2	Enter in  the respective change room (Gents will enter through gents change
			room and Ladies will enter through ladies change room).
		5.1.3	Follow the gowning procedure.
		5.1.4	Staff will wear white apron, while  workers will follow dress code of secondary   packing worker.
		5.1.5	Remove the street footwear, keep in the rack provided and wear the laboratory   Footwear.
		5.1.6	Enter to wide corridor leading to main QC door.
		5.1.7	Enter at the main QC door and proceed to respective rooms / section.
	5.2	EXIT FROM QUALITY CONTROL DEPARTMENT
		5.2.1	Exit the respective rooms / sections and come to  the wide QC corridor.
		5.2.2	Enter in to the wide corridor.
		5.2.3	Enter in respective change room (Gents will enter to gents change room and
			Ladies will enter to ladies change room).
		5.2.4	Remove the laboratory footwear in the rack provided.
		5.2.5	Exit from the respective change room by following the procedure for degowning.
		5.2.6	Keep the set of factory uniforms in the individual lockers or put in the container for Washing purpose.
6.0	ABBREVIATIONS:
	Abbreviation Expanded form QC Quality  Control
7.0	ANNEXURES: NIL
8.0	SOP REFERENCES:
	GLP Guidelines
9.0	SOP REVISION HISTORY RECORD:
	Revision Details for change Effective date 01
	END OF THE SOP

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