Related substances in official drugs

Related substance present in good number of official drugs may be determined by GLC method, for instance Bromopheneramine maleate Bronopol Cepahloridine Chlorocresol Chloroform Chloroxylenol., Cindamycin hydrochloride Griseofulvin Isometheptene mucate Levomenthol  

Materials Required Solution (1) dilute 1 volume of solution (3) to 200 volumes with a 0.005% w/v solution of N-phenylcarbazole (internal standard) in toluence 10 ml Solution (2) (add 5 ml of DW to 0.1 g of bromopheneramine maleate sample, make the resulting solution alkaline with 13.5 M ammonia, add 2.5 ml of toluene, shake for 5 minutes, centrifuge and use the upper layer) solution (3) (prepare it exactly in the same manner as solution- 2 but using the internal standard solution in place of toluene) Solution (4) (dissolve 10 mg of bromopheneramine maleate BPCRS in 5 ml of DW, make alkaline with 13.5 M ammonia, add 2.5 ml of toluene, shake for 5 minutes, centrifuge and dilute 1 volume of the upper layer to 20 volumes with toluene)  

Column Glass column size (1.5 m x 4 mm) adsorbent packed with acid-washed, silanized diatomaceous support ( 80 to 100 mesh) impregnated with 3% of phenyl methyl silicone fluid (50% phenyl) and maintained at 220 °C. 

Procedure After having maintained the aforesaid experimental parameter for gas chromatography, inject 1 g/ each of solutions (1), (2), (3) and (4) in a sequential manner. 

Name Substance Chromatographic Conditions Sample Injection Qty. Solutions for GLC Calculations/ Observations 

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Table 29.4 Cognate Determinations of Related Substances in Official Drugs ...

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