Durgababu Rapeti, Kapavarapu Maruthi Venkata Narayanarao, Pulipaka Shyamala, Rallabhandi Murali Krishna
Durgababu Rapeti1*, Kapavarapu Maruthi Venkata Narayanarao1, Pulipaka Shyamala2, Rallabhandi Murali Krishna3
1GVK Biosciences Pvt Ltd, Hyderabad, Telangana, India – 500076.
2Physical Chemistry Department, Andhra University, Visakhapatnam, Andhra Pradesh, India – 530003.
3Department of Physical and Nuclear chemistry, and Department of Chemical Oceanography, Andhra University, Visakhapatnam, Andhra Pradesh, India – 530003.
Volume - 14,
Issue - 11,
Year - 2021
Trimetazidine dihydrochloride (TD) is an anti-ischemic drug that is used to effectively treat angina pectoris symptoms. During the manufacture of TD from gallic acid a process related impurity, pyrogallol, is produced. Up to the present time, no appropriate method has been proposed for the detection and analysis of pyrogallol in the TD at the level of threshold of toxicological concern. Therefore, in this investigation, a reliable and reproducible HPLC method was developed for the detection and analysis of pyrogallol in the TD. The method was validated in full compliance with the recommendations of the International Harmonization Council. Regression analysis indicated a correlation coefficient value of 0.9990 for pyrogallol between 6.3 ppm and 31.5 ppm. The LOD was 1.89 ppm and LOQ was 6.3 ppm for pyrogallol. Good recovery (accuracy) was observed in the range of 98.34% to 118.54 % with an RSD value (precision) of 0.150%. Pyrogallol analysis in batches TD material has demonstrated the good performance of the method. The process is therefore useful in the identification and evaluation of pyrogallol content in drug substance of TD.
Cite this article:
Durgababu Rapeti, Kapavarapu Maruthi Venkata Narayanarao, Pulipaka Shyamala, Rallabhandi Murali Krishna. Method Development and Validation for Pyrogallol Content Quantification by HPLC in Trimetazidine Dihydrochloride. Research Journal of Pharmacy and Technology. 2021; 14(11):5803-7. doi: 10.52711/0974-360X.2021.01009
Durgababu Rapeti, Kapavarapu Maruthi Venkata Narayanarao, Pulipaka Shyamala, Rallabhandi Murali Krishna. Method Development and Validation for Pyrogallol Content Quantification by HPLC in Trimetazidine Dihydrochloride. Research Journal of Pharmacy and Technology. 2021; 14(11):5803-7. doi: 10.52711/0974-360X.2021.01009 Available on: https://rjptonline.org/AbstractView.aspx?PID=2021-14-11-34
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