Anhui Fengyuan Pharmaceutical Co., Ltd.

Objective: To sep. and determine tetrapeptide degradation impurities in alanyl glutamine injection by HPLC.Methods: The HPLC condition was performed with an amino bonded silica gel column.The mobile phase was 0.1 mol/L formic acid solution(adjusted to pH 3.5 with ammonia)-acetonitrile(32:68), the detection wavelength was 215 nm, the flow rate was 0.8 mL/min, and the colunm temperature was 35°C.Results: Alanyl glutamine and various types of degradation impurities in the sample was separated well, and the detection limit of each impurity fully satisfied detection requirements.Conclusion: The method is highly specific, accurate and reliable.It is applicable to determine tetrapeptide degradation impurities in alanyl glutamine injection.

Synthesis process of naftopidil was studied.Naftopidil was successfully synthesized using 1-naphthol and epichlorohydrin as materials.The two materials firstly reacted in the presence of phase transfer catalyst TEBA, then directly reacted with 1-(3-methoxyphenyl) piperazine.The optimal synthesis conditions of naftopidil: molar ratio of product I and II is 1:1 and reaction temperature is 60°C.The synthetic route of the process is simple, the reaction conditions were mild, the product is easily purified, and the process is very suitable for industrialization.

The stability of injectable ATP and its injection preparation was studied and compared.The accelerated test and long test run were conducted for three batches of freeze drying products and injection solutionThe each index including the content variation was determined and compared with the original data and between the two preparations during the tests.The results showed that the each index was consistent with the standard during the tests.The content variations with time were significantly different for the two preparationsThe injectable ATP is more stable than its injection, and the term of validity is set to 2 years.