Pallab Mandal, Pradip Kundu, Soumya Chakraborty, Rakesh Bera, Nilendra Chatterjee, Sourav Poddar, D.P. Ghosh, Tapan Kumar Pal
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Pallab Mandal1, Pradip Kundu2, Soumya Chakraborty1, Rakesh Bera1, Nilendra Chatterjee1, Sourav Poddar3, D.P. Ghosh2, Tapan Kumar Pal1*
1TAAB Biostudy Services, Jadavpur, Kolkata 700032, India.
2Albert David Limited, Block-D, 3rd Floor, Gillander House, 8, Netaji Subhas Road, Kolkata - 700001, India.
3National Institute of Technology, Tiruchirappalli, Tamil Nadu – 620015.
Volume - 15,
Issue - 9,
Year - 2022
The phosphocholine and phospholipid that is hexadecyl monoester of phosphocholine (alkyl phospholipid) is a miltefosine drug used to treat all types of leishmaniasis. It is a broad-spectrum antimicrobial, anti-leishmanial, anti-cancer phospholipid drug. It is used for the treatment of breast cancer and cutaneous metastasis. This present study of miltefosine was given to develop. It validated the analytical method by LC-MS/MS (API-2000). It will be applied to the estimation of miltefosine from its solubility sample, force degradation sample, dissolution sample, and impurity analysis. The calibration concentrations of miltefosine were 125, 250, 500, 1000, 2000, and 4000 ng/ml which accuracy was 90.903 – 109.077% and reported stability was 90.71- 97.99%, 92.04 – 98.02%, 90.00 – 95.52%, 89.72 – 98.54% for freeze-thaw, short term, benchtop, autosampler stability respectively. The developed method for determining and quantifying miltefosine in the sample was also validated as per the US-FDA and EMA guidelines. The validation parameters found within the specified regulatory limit, hence acceptable. The present method also has a short run time (6.00 min). The method is simple, specific, highly selective, sensitive, and reproducible.
Cite this article:
Pallab Mandal, Pradip Kundu, Soumya Chakraborty, Rakesh Bera, Nilendra Chatterjee, Sourav Poddar, D.P. Ghosh, Tapan Kumar Pal. Analytical Method Development and Validation of Trimethylazanium containing Anti-leishmanial Phospholipid Drug Miltefosine by Liquid Chromatography Quadruple Tandem Mass Spectrometry (LC-ESI-MS/MS) API-2000. Research Journal of Pharmacy and Technology. 2022; 15(9):4128-4. doi: 10.52711/0974-360X.2022.00693
Pallab Mandal, Pradip Kundu, Soumya Chakraborty, Rakesh Bera, Nilendra Chatterjee, Sourav Poddar, D.P. Ghosh, Tapan Kumar Pal. Analytical Method Development and Validation of Trimethylazanium containing Anti-leishmanial Phospholipid Drug Miltefosine by Liquid Chromatography Quadruple Tandem Mass Spectrometry (LC-ESI-MS/MS) API-2000. Research Journal of Pharmacy and Technology. 2022; 15(9):4128-4. doi: 10.52711/0974-360X.2022.00693 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-9-53
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