The author of 《Quality by Design (Qbd) Approach to Develop HPLC Method for Estimation of Gliclazide and its Impurity (Gliclazide Impurity A) in Bulk Drug》 were Vijayaraj, Surendran; Palei, Narahari N.; Katyayani, Thummala. And the article was published in Current Pharmaceutical Analysis in 2019. Safety of 4-Methylbenzenesulfonamide The author mentioned the following in the article:
Background: Gliclazide Impurity A (GI-A) is one of the gliclazide impurities, as described in the European Pharmacopoeia. Objective: The objective of this study was to develop and validate simple, robust and accurate Reverse- Phase High-Performance Liquid Chromatog. (RP-HPLC) method for estimation of gliclazide along with GI-A in bulk by optimizing chromatog. parameters using Box Behnken design in response surface methodol. Methods & Results: Box Behnken design was employed for optimizing flow rate, injection volume and strength of the buffer in order to minimize retention time of both gliclazide and GI-A. The optimized strength of orthophosphoric acid buffer in a mixture of Acetonitrile (50:50 volume/volume), flow rate and injection volume were found to be 25mM, 1mL/min, 20μL resp. Linearity was observed in concentration range of 25-150μg/mL (r2=0.999). The retention time of gliclazide and GI-A was found to be 5.799 min and 3.819 min, resp. The limit of detection for Gliclazide and GI-A was found to be 0.0066, and 0.0075μg/mL and the limit of quantification limit was found to be 0.0202, 0.0228μg/mL, resp. The developed method was validated as per the ICH guidelines. Conclusion: The proposed method is useful for best anal. of Gliclazide and GI-A in pharmaceutical dosage forms. QbD approach was found to be an effective tool for optimizing chromatog. conditions of the proposed method.4-Methylbenzenesulfonamide(cas: 70-55-3Safety of 4-Methylbenzenesulfonamide) was used in this study.
4-Methylbenzenesulfonamide(cas: 70-55-3) belongs to anime. Acylation is one of the most important reactions of primary and secondary amines; a hydrogen atom is replaced by an acyl group (a group derived from an acid, such as RCOOH or RSO3H, by removal of ―OH, such as RC(=O)―, RS(O)2―, and so on). Reagents may be acid chlorides (RCOC1, RSO2C1), anhydrides ((RCO)2O), or even esters (RCOOR′); the products are amides of the corresponding acids.Safety of 4-Methylbenzenesulfonamide
Referemce:
Amide – Wikipedia,
Amide – an overview | ScienceDirect Topics