Prescription screening and stability investigation of concentrated benzoic acid and salicylic acid ointments with PEG as the matrix
- Author:
Feng FU
1
Author Information
1. Department of Pharmacy
- Publication Type:Journal Article
- Keywords:
Benzoic acid;
HPLC;
Ointment;
Quality standard;
Salicylic acid
- From:
Chinese Pharmaceutical Journal
2012;47(22):1829-1833
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE: To study the preparation of concentrated benzoic acid and salicylic acid ointment and establish the quality control system. METHODS: To choose the best basic formula with orthogonal design test. The ointment was prepared by ethanol or DMSO as the solvent for benzoic acid and salicylic acid, and PEG400 and PEG4000 were used as the water-soluble ointment matrix. To establish the quality control method such as character, identification, inspection and content determination etc. In addition, the permanent stability investigation was conducted to ointment product. RESULTS: The new prescription has solved the unqualified granularity problem. The results of the permanent stability investigation meet the standards of Chinese Pharmacopoeia. Contents of benzoic acid and salicylic acid were simultaneously measured by HPLC; the average recoveries were within 99.6%-100.6%, 99.4%-100.2%, respectively; the RSDs were 0.52% and 0.39%, respectively. CONCLUSION: The ointment is easy to prepared and the quality is stable. The quality control method is reliable.
