Analytical Method Development And Validation Of RP-HPLC Method For Estimation Of Lumateperone In Bulk And Pharmaceutical Dosage Form

Authors

  • Darshana Undre
  • Vaibhav Shilimkar

Keywords:

Lumateperone Tosylate, UV-Visible Spectrophotometry, RP-HPLC, Method Validation, ICH Guidelines, Pediatric Dosage

Abstract

Objective:
To develop and validate precise, accurate, and robust analytical methods—UV-Visible Spectrophotometry and Reversed Phase High-Performance Liquid Chromatography (RP-HPLC)—for the estimation of Lumateperone Tosylate in bulk and pharmaceutical dosage forms.

Methods: The UV spectrophotometric method involved selecting 227 nm as the analytical wavelength using a 50:50 v/v water:methanol diluent. Linearity was established between 5–15 µg/mL (R² = 0.9997).

The RP-HPLC method was developed using a Phenomenex C18 column with a mobile phase of phosphate buffer (pH 6.0):methanol (55:45 v/v), a flow rate of 1.2 mL/min, and detection at 227 nm. Validation parameters such as accuracy, precision, linearity, system suitability, and robustness were assessed following ICH Q2(R1) guidelines¹.

Results: The UV method demonstrated good linearity (R² = 0.9997), recovery (98.0%–102.0%), and precision (RSD < 2%). The optimized HPLC method (retention time ~4.1 min) showed acceptable asymmetry (1.21) and theoretical plates (>7500), with consistent assay results and % RSD within limits. The methods were successfully applied for quantitative estimation of Lumateperone in capsules².

Conclusion: Both methods were simple, reliable, and suitable for routine quality control of Lumateperone. These findings provide an analytical foundation for future pediatric formulation development of Lumateperone, pending neonatal pharmacokinetic research³.

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References

ICH Q2(R1). Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonisation, 2005.

FDA. Caplyta (Lumateperone) Prescribing Information.

Indian Pharmacopoeia, 2022.

Skoog DA, Holler FJ, Crouch SR. Principles of Instrumental Analysis. 6th ed.

Bakshi M, Singh S. Development of validated stability-indicating methods. J Pharm Biomed Anal. 2002;28(6):1011–1040.Rudra A, Chatterjee S, Sengupta S, Wankhede R, Nandi B, Maitra G, Mitra J. Management of obstetric hemorrhage. Middle East J Anaesthesiol 2010;20:499-507.

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Published

2025-07-07

How to Cite

1.
Undre D, Shilimkar V. Analytical Method Development And Validation Of RP-HPLC Method For Estimation Of Lumateperone In Bulk And Pharmaceutical Dosage Form. J Neonatal Surg [Internet]. 2025Jul.7 [cited 2025Oct.11];14(32S):3967-78. Available from: https://www.jneonatalsurg.com/index.php/jns/article/view/8059

Issue

Vol. 14 No. 32S (2025): Journal of Neonatal Surgery

Section

Original Article

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