Comformity study of formulation and manufacture process for bromohexine hydrochloride parenteral preparations using Near-infrared and Raman spectroscopy

doi:10.19803/j.1672-8629.20230435

Abstract

Abstract: Objective To establish qualitative models of Near-infrared spectroscopy for the conformity investigation of bromohexine hydrochloride powder for injection in terms of formulation and manufacture process, develop quantitatvie models of Near-infrared spectroscopy for the determination of bromohexine of bromohexine hydrochloride powder for injection. To develop Raman spectroscopy qualitative models to investigate the conformity of formulation and manufacture process for bromohexine hydrochloride injections and infusions. Methods The Near-infrared and Raman spectra of bromohexine hydrochloride parenteral preparations (powder for injection, injections and infusions) selected for evaluative sampling were investigated: Near-infrared spectroscopic qualitative and quantitative models were established for bromohexine hydrochloride powder for injection. Raman spectroscopy-principal component analysis was used to study bromohexazine hydrochloride injections and infusion. Results Near-infrared and Raman conformity models for bromohexine hydrochloride powder for injection of two manufacturers was established, and the prediction success rate was 100%. The principal component analysis method was used to study the conformity of powder for injection, injections and infusions. The results corresponded to the conformity models reflected the similarity of the formulation and manufacture process. The Near-infrared quantitative models showed to be robust and accurate for the determination of the content of bromohexine hydrochloride. Conclusion Near-infrared spectroscopy and Raman spectroscopy can be used to identify Bromohexine Hydrochloride Parenteral preparations (powder for injection, injections and infusions) with stable quality process. Near-infrared spectroscopy quantitative model can be used to predict the content of bromohexine for bromohexine hydrochloride powder for injection and enables rapid detection, screening as well as process control and release.

Key words: bromohexine, injection, comformity model, quantitative models, Near-infrared spectroscopy, Raman spectroscopy, principal component analysis

CLC Number:

R927.1

GENG Ying, LIU Yi, WANG Xuelei, ZHU Rongdie, JIN Ying, CHEN Hua, ZHENG Li'e. Comformity study of formulation and manufacture process for bromohexine hydrochloride parenteral preparations using Near-infrared and Raman spectroscopy[J]. Chinese Journal of Pharmacovigilance, 2024, 21(3): 300-306.

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