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Product Description

Tolperisone Hydrochloride

Description of Analytical Procedure

The assay method of Tolpropofol Hydrochloride is based on the potentiometric titration used in JP17. Compared with the use of crystal violet indicator in domestic specification, the titration endpoint can be determined more accurately; according to General Chapter 0702, Volume IV, Chinese Pharmacopoeia 2020, the result indicates that the sample consumption is about 8 ml, and the sample size is calculated to be about 0.25 g. Therefore, this condition is used in the analytical procedure for assay of Tolpropofol Hydrochloride.

Validation Summary

The validation of analytical procedure for assay of Tolpropofol Hydrochloride mainly includes specificity, precision, linearity and range, accuracy and robustness.

According to the validation data obtained from the test, the results of all validation items meet the requirements of the analytical procedure validation protocol, indicating that the analytical procedure meets its intended use and purpose.

The chromatogram in the validation of analytical procedure is provided in Attachment 1 Chromatogram for Validation of Analytical Procedure for Tolpropofol Hydrochloride in 3.2.S.4.

Analytical Procedure

1 Solution Preparation

(1) Diluent

Mix an appropriate amount of acetic anhydride and glacial acetic acid at a ratio of 7:3.

(2) Test solution

Accurately weigh about 0.25 g of the dried product, transfer into a 100 ml titration vessel, and dissolve with 35 ml of diluent. Prepare in duplicate.