Alclometasone Dipropionate

Alclometasone dipropionate is a synthetic glucocorticoid corticosteroid and a corticosteroid ester. At is an Active raw material for different products in pharmaceutical industry. CHEMICAL FORMULA C23H37ClO7 CHEMICAL STRUCTURE
Alclometasone dipropionate
Alclometasone dipropionate
DEFINITION Alclometasone Dipropionate contains not less than 97.0% and not more than 102.0% of C23H37ClO7 calculated on the dried basis. ASSAY (HPLC PROCEDURE) MOBILE PHASE: Methanol and Solution A in ratio (2: 1) SOLUTION A: 6.80 mg/ml of monobasic potassium phosphate (0.05 M) INTERNAL STANDARD SOLUTION: 2 mg/ml of betamethasone dipropionate in methanol STANDARD STOCK SOLUTION: 1.2 mg/ml of Alclometasone Dipropionate reference standard in methanol STANDARD SOLUTION: 4.0 ml of Standard stock solution and 4.0 ml of Internal standard solution. Dilute with methanol to 25 ml. ( this solution contains 0.2 mg/ml of Alclometasone Dipropionate reference standard.) SAMPLE STOCK SOLUTION: 1.2 mg/ml of Alclometasone Dipropionate in methanol SAMPLE SOLUTION: 4 ml of Sample stock solution and 4 ml of Internal standard solution. Dilute with methanol to 25 ml. CHROMATOGRAPHIC SYSTEM Mode: LC Detector: UV 254 nm Column: 4-mm x 30-cm; packing L 1 Flow rate: 1.2 ml/min Injection size: 10 µL  RELATIVE STANDARD DEVIATION Relative Standard Deviation should not be more than 2%. CALCULATION %age Assay =   Hs/Ha × Ca/Cs × 100 Hs = Peak height ratio from the Sample solution Ha = peak height ratio from the Standard solution Ca = concentration of Alclometasone Dipropionate in the Standard solution (mg/ml) Cs = concentration of the Sample solution (mg/ml) ACCEPTANCE CRITERIA: 97.0%  -  102.0% on the dried basis IMPURITIES
  • INORGANIC
RESIDUE ON IGNITION: Should be Not More Than 0.1%. HEAVY METALS: Should be Not More Than 30ppm.
  • Organic
HPLC-PROCEDURE MOBILE PHASE: Acetonitrile and water (3:2) DILUENT: Acetonitrile and water (2:1) SYSTEM SUITABILITY SOLUTION: 1.5 mg/ml of Alclometasone Dipropionate reference standard and 0.015 mg/ml of Alclometasone Dipropionate Related Compound in Diluent SAMPLE SOLUTION: 1.5 mg/ml of Alclometasone Dipropionate in Diluent CHROMATOGRAPHIC SYSTEM Mode: LC Detector : UV 254 nm Column: 4.6-mm x 15-cm; 5 µm packing L1 Flow rate: 1 ml/min Injection size: 5 µL Run time: Three times the retention time of alclometasone Tailing factor: NMT 1.5 for alclometasone dipropionate Relative standard deviation: NMT 2.0% for alclometasone dipropionate Resolution: NLT 2.0 between alclometasone dipropionate and alclometasone dipropionate related compound A CALCULATION Ai/Aa × 1/F × 100 Ai = Peak area for each impurity from the sample solution Aa = Sum of all peaks from sample solution F = Relative response factor ACCEPTANCE CRITERIA: Total impurities should be not more than 2.0%. SPECIFIC TESTS
  • OPTICAL ROTATION :
Sample solution: 30 mg/ml in dioxane Acceptance criteria: +21°  to  +25°
  • Loss on Drying: Dry a sample in a vacuum at a pressure not exceeding 5 mm of mercury at 105° for 3 h:
It loses NMT 0.5% of 1ts weight.  

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