Liquid Chromatographic Method Development and Validation for Estimation of Amisulpride in Pharmaceutical Dosage Form
Abstract
Amisulpride was quantified using a simple and reliable HPLC technique developed and validated. Acquity BEH C18 (150 x 3.0mm, 1.7µm) column as stationary phase was used to achieve chromatographic segregation. The mobile phase was a phosphate buffer pH 6.5, and acetonitrile (60:40, v/v) was pumped through the column. The wavelength of the ideal choice was 248 nm. The amisulpride retention time was discovered to be 4.25 minutes. The amisulpride regression equation yielded LOD and LOQ values of 0.15µg/ml and 0.47µg/ml, respectively. The percentage of recovery of amisulpride was found to be between 99.89 and 102.32 %, respectively. The regression equation was found to be y = 44556x + 22947. Since run time and retention time were minimized, the system developed was simple and cost-effective, and it could be used for routine analysis in quality control.
Keywords: RP-HPLC, Amisulpride, Peak area, Retention time, Accuracy, Validation.
Keywords:
RP-HPLC, Amisulpride, Peak area, Retention time, Accuracy, ValidationDOI
https://doi.org/10.22270/jddt.v15i6.7211References
1. Kranke P, Bergese SD, Minkowitz HS, Melson TI, Leiman DG, Candiotti KA, Liu N, Eberhart L, Habib AS, Wallenborn J, Kovac AL, Diemunsch P, Fox G, Gan TJ. Amisulpride Prevents Postoperative Nausea and Vomiting in Patients at High Risk: A Randomized, Double-blind, Placebo-controlled Trial. Anesthesiology. 2018;128:1099. https://doi.org/10.1097/ALN.0000000000002133
2. Juruena M, De Sena, De Oliveira I. Specific mechanism of action of amisulpride in the treatment of schizophrenia and correlation with clinical response and tolerability. Journal of Receptor, Ligand and Channel Research. 2011;4:49. https://doi.org/10.2147/JRLCR.S6239
3. Manoja KML, Gurupadayya BM, Srujana S, Raaga LV. Development and validation of stability indicating RP-HPLC method for amisulpride in bulk and pharmaceutical formulation. Indian Drugs.2012;49:43. https://doi.org/10.53879/id.49.04.p0043
4. Musenga A, Mandrioli R, Morganti E, Fanali S, Raggi MA. Enantioselective analysis of amisulpride in pharmaceutical formulations by means of capillary electrophoresis. Journal of Pharmaceutical and Biomedical Analysis. 2007;46:966. https://doi.org/10.1016/j.jpba.2007.05.022.
5. Ramakotaiah M, Kanchanamala K, Balasekhara RC, Babu Rao C, Chandrasekhar KB. Development and validation of amisulpride in human plasma by HPLC coupled with tandem mass spectrometry and its application to a pharmacokinetic study. Scientia Pharmaceutica. 2011;79:583. https://doi.org/10.3797/scipharm.1105-12
6. Kamal S, Mohammad E, Dima S, Gada I, Tawfig A. Study of forced degradation behavior of amisulpride by LC-MS and NMR and development of a stability-indicating method. Current Pharmaceutical Analysis. 2018;14:157. https://doi.org/10.2174/1573412913666170822162009
7. Papoutis L, Anna R, Chara S, Constantinos P. Validated GC-MS method for the determination of amisulpride in whole blood. Journal of Chromatography B. 2017; 948:111. https://doi.org/10.1016/j.jchromb.2013.12.024.
8. ICH Validation of analytical procedures: Text and Methodology Q2 (R1), International Conference on Harmonization, (2005).
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