Liquid Chromatographic Method Development and Validation for Estimation of Amisulpride in Pharmaceutical Dosage Form

Authors

  • R Baby Nalanda Department of Pharmaceutical Analysis and Quality Assurance, GITAM School of Pharmacy, GITAM University, Visakhapatnam-530045, India. https://orcid.org/0000-0002-9314-2459
  • S Kapileswar Department of Pharmaceutical Analysis and Quality Assurance, GITAM School of Pharmacy, GITAM University, Visakhapatnam-530045, India.

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, Validation

DOI

https://doi.org/10.22270/jddt.v15i6.7211

Author Biographies

R Baby Nalanda , Department of Pharmaceutical Analysis and Quality Assurance, GITAM School of Pharmacy, GITAM University, Visakhapatnam-530045, India.

Department of Pharmaceutical Analysis and Quality Assurance, GITAM School of Pharmacy, GITAM University, Visakhapatnam-530045, India.

S Kapileswar, Department of Pharmaceutical Analysis and Quality Assurance, GITAM School of Pharmacy, GITAM University, Visakhapatnam-530045, India.

Department of Pharmaceutical Analysis and Quality Assurance, GITAM School of Pharmacy, GITAM University, Visakhapatnam-530045, India.

References

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Published

2025-06-15
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How to Cite

1.
Nalanda RB, Kapileswar S. Liquid Chromatographic Method Development and Validation for Estimation of Amisulpride in Pharmaceutical Dosage Form. J. Drug Delivery Ther. [Internet]. 2025 Jun. 15 [cited 2026 Feb. 2];15(6):145-9. Available from: https://www.jddtonline.info/index.php/jddt/article/view/7211

How to Cite

1.
Nalanda RB, Kapileswar S. Liquid Chromatographic Method Development and Validation for Estimation of Amisulpride in Pharmaceutical Dosage Form. J. Drug Delivery Ther. [Internet]. 2025 Jun. 15 [cited 2026 Feb. 2];15(6):145-9. Available from: https://www.jddtonline.info/index.php/jddt/article/view/7211