Montelukast Sodium Testing Procedure and Raw Material specification & analysis prescribes the requirements with UV Spectrophotometer spectrum and Alternate Method of Analysis on HPLC System and Other Testing procedures.
Characters
Spread about 1.0 of sample on a clean, dry watch glass and observe the appearance, it should be white crystalline powder and determination.
Solubility
(i) Take approximately 0.5 gram of sample into a clean test tube containing water. Close the test tube with stopper and shake well. The sample slightly soluble in water.
(ii) Take approximately 0.5 gram of sample into a clean test tube containing alcohol. Close the test tube with stopper and shake well. The sample slightly soluble in alcohol.
(iii) Take approximately 0.5 gram of sample into a clean test tube containing methanol. Close the test tube with stopper and shake well. The sample slightly soluble in methanol.
(iv) Take approximately 0.5 gram of sample into a clean test tube containing ether. Close the test tube with stopper and shake well. The sample practically insoluble in ether.
Identification
BY UV Ultraviolet Absorption
Solution: 6 µg/ml
Medium: 0.1N Sodium hydroxide
Limit: – Sample solution absorbance should correspond to standard solution absorbance.
Loss on drying
Not more than 0.5%, determined on 1.0 g by drying in an oven at 100°C to 105°C for 4 hrs.
Procedure: Take a clean and dry wide mouth weighing bottle that has been dried at 105± 2 0C in oven for 30 minutes and cool to room temperature in a desiccator then weigh it (W1). Transfer about 1 grams of sample into the weighing bottle. Weigh the bottle and note down the weight (W2). Calculate the net weight of the sample (W2-W1). Gently shake the bottle to distribute the material evenly. Place the weighing bottle in oven. Remove the stopper and keep it by the side of the weighing bottle or petridish. Close the oven, and dry it at 105 0C for 4 hours. Stop drying, and cool to room temperature. Open the chamber and close the weighing bottle promptly with stopper. Weigh the bottle and note down the weight W3. Calculate the % loss on drying using the formula.
% of Loss on Drying = W2-W3 x 100
W2-W1
SUMMARY:
The determination of MONTELUKAST (as SODIUM) is achieved through its specific absorbance at 225 nm in Methanol ,
SAFETY PRECAUTIONS:
Good laboratory practices dictate that each analyst should be thoroughly acquainted with potential hazard of the reagents, products, and solvents. Safety information on reagents
may be obtained from the suppliers.
SCOPE:
The method is used to assay MONTELUKAST (AS SODIUM)
SPECIAL APPARATUS, REAGENTS AND SOLUTION
Montelukast Sodium Testing Procedure
UV / Vis. Spectrophotometer.
MONTELUKAST (AS SODIUM) reference standard.
PREPARATION OF STANDARD SOLUTION:
Accurate weight about 100mg of MONTELUKAST (AS SODIUM)standard and quantitatively transfer it into a 100ml volumetric flask. Add about 50 – 60ml Methanol ,shake for 5 – 10 minutes and dilute to volume with the same solvent. Filter, discarding the first parts of the filtrate (30 – 40ml) and Take 1 ml of the clear solution into a 100ml volumetric flask and diluted to the mark with Methanol
PREPARATION OF THE SAMPLE SOLUTION:
Accurate weight about 100mg of MONTELUKAST (AS SODIUM)sample and quantitatively transfer it into a 100ml volumetric flask. Add about 50 – 60ml Methanol ,shake for 5 – 10 minutes and dilute to volume with the same solvent. Filter, discarding the first parts of the filtrate (30 – 40ml) and Take 1 ml of the clear solution into a 100ml volumetric flask and diluted to the mark with Methanol
PROCEDURE:
Measure the absorbance of the solutions (Standard and Sample) at 225nm using Methanol as blank.
Calculate the assay by using following formula
%age MONTELUKAST = AS × Wst × 1× 100 × 100 × P × 100
Ast × 100 × 100 × WS × 1
Where C is the %age Potency of the MONTELUKAST SODIUM
LIMIT– Contents should l between 98——102 % ( ANHYDROUS BASIS)