Syrups pseudoephedrine hydrochloride

Add items 6 and 7 while mixing to dissolve at high speed. 

Add item 2 while mixing at slow speed. Temperature 90° to 95°C. 

Dissolve items 8 and 12 in 10.0 g of item 13 and add to the manufacturing vessel while mixing at high speed. 

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Pseudoephedrine hydrochloride can be considered a stable compound in bulk and in formulations. After 4-weeks under fluorescent lights (2400 ft. candles) and ultraviolet light (190 pw/cm2) no discoloration or chemical degradation was observed. The bulk drug was stable for at least 6 months at 37°C and 3 months at 50°C. Tablet and syrup formulations stored at 15-30°C for 5 years showed no appreciable degradation. 13... 

An ultraviolet spectrophotometric method based on the absorbance of a periodate oxidation product of pseudoephedrine hydrochloride will be the official method of analysis in the USP XX.19,20 A portion of tablets or syrup in water is placed in a separatory funnel. Sodium bicarbonate and sodium metaperiodate are added. After standing for 15 minutes, 1 N HC1 is added. The solution is extracted with hexane. The hexane extract is filtered and its absorbance determined at 242 nm in 1 cm cells. The amount of the oxidation product of pseudoephedrine hydrochloride is determined by comparison of the sample absorbance against the absorbance of a Pseudoephedrine Hydrochloride Reference Standard treated in the same manner. 

Pseudoephedrine hydrochloride in syrup formulations has been analyzed by colorimetry. Pseudoephedrine forms a stable blue-colored chelate with cupric sulfate at pH 12.5. The complex has a maximum absorbance at 500 nm. The complex is extracted from an aqueous layer with 1-pentanol. Interfering substances such as glycerine and sugars normally found in syrup formulations, which form complexes with cupric sulfate, are not extracted into 1-pentanol.21... 

The obtained results indicated that this procedure could be applied for the determination of ibuprofen, pseudoephedrine hydrochloride, chlorpheniramine maleate and nipagen in syrup preparations. 

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