Comprehensive Stability Analysis of Haloperidol: Insights from Advanced Chromatographic and Thermal Analysis DOI Open Access

Khadidja Djilali,

Rachida Maachi,

Hocine Boutoumi

et al.

Processes, Journal Year: 2025, Volume and Issue: 13(3), P. 904 - 904

Published: March 19, 2025

In this study, we thoroughly investigated the stability of haloperidol using a comprehensive set chromatographic and thermal analyses. Various stress conditions were examined, including exposure to oxidizing agents (such as hydrogen peroxide), dry heat, photolytic conditions, acid alkaline hydrolysis. Significant degradation was observed in acidic environments, leading formation by-products, specifically DPA, DPB, DPC, DPD for basic conditions. contrast, demonstrated robust under photolytic, oxidative, dry-heat For analysis drug its products, C-18 column employed, coupled with mobile phase consisting methanol phosphate buffer (pH = 9.8) 90:10 (v/v) ratio. The analytical method rigorously validated according ICH Q2 (R1) guidelines, ensuring accuracy reliability. This exhibited excellent linearity within concentration range 1 50 µg/mL, an R2 0.999. Additionally, is applicable commercial formulations, without need prior extraction. LC-MS/MS revealed distinct m/z values fragmentation spectra corresponding impurity not documented European Pharmacopoeia monograph drug. Three additional products identified based on base fragments. Thermal analyses, thermogravimetric (TGA), differential scanning calorimetry (DSC), (DTA), provided further evidence active ingredient’s stability, melting temperature approximately 150 °C. These results collectively offer valuable insights into behavior haloperidol, providing critical implications pharmaceutical quality integrity various environmental

Language: Английский

Comprehensive Stability Analysis of Haloperidol: Insights from Advanced Chromatographic and Thermal Analysis DOI Open Access

Khadidja Djilali,

Rachida Maachi,

Hocine Boutoumi

et al.

Processes, Journal Year: 2025, Volume and Issue: 13(3), P. 904 - 904

Published: March 19, 2025

In this study, we thoroughly investigated the stability of haloperidol using a comprehensive set chromatographic and thermal analyses. Various stress conditions were examined, including exposure to oxidizing agents (such as hydrogen peroxide), dry heat, photolytic conditions, acid alkaline hydrolysis. Significant degradation was observed in acidic environments, leading formation by-products, specifically DPA, DPB, DPC, DPD for basic conditions. contrast, demonstrated robust under photolytic, oxidative, dry-heat For analysis drug its products, C-18 column employed, coupled with mobile phase consisting methanol phosphate buffer (pH = 9.8) 90:10 (v/v) ratio. The analytical method rigorously validated according ICH Q2 (R1) guidelines, ensuring accuracy reliability. This exhibited excellent linearity within concentration range 1 50 µg/mL, an R2 0.999. Additionally, is applicable commercial formulations, without need prior extraction. LC-MS/MS revealed distinct m/z values fragmentation spectra corresponding impurity not documented European Pharmacopoeia monograph drug. Three additional products identified based on base fragments. Thermal analyses, thermogravimetric (TGA), differential scanning calorimetry (DSC), (DTA), provided further evidence active ingredient’s stability, melting temperature approximately 150 °C. These results collectively offer valuable insights into behavior haloperidol, providing critical implications pharmaceutical quality integrity various environmental

Language: Английский

Citations

1