Development of a Validated RP-HPLC/UV Method for the Quantitative Determination of Tyrosine Kinase RET Inhibitor: Selpercatinib in Capsule Formulation

Authors

  • Paka Ramya Department of Pharmaceutical Chemistry, Geethanjali College of Pharmacy, Cheeryal (V), Keesara (M), Medchal (D), Hyderabad-501301.
  • Medidi Srinivas Department of Pharmaceutical Chemistry, Geethanjali College of Pharmacy, Cheeryal (V), Keesara (M), Medchal (D), Hyderabad-501301. https://orcid.org/0000-0002-6028-5744
  • Bula Udaya Kumari DSK Biopharma Inc, 112 Nova Dr, Morrisville, NC 27560, USA.

Abstract

A validated RP-HPLC/UV method was developed to estimate the selpercatinib in capsules. The wavelength chosen for detection was at 248 nm. The RP-HPLC separation was carried out using a Hypersil ODS C18 column (250×4.6 mm, 5 μm) with a mobile phase consisting of 0.2% TFA (pH 6.5) and acetonitrile in a ratio of 70:30 v/v. The flow rate was set at 1 ml/min. The retention time for selpercatinib was determined to be 3.012 min.  Linearity was detected within the concentration range of 2.5-15 μg/mL for selpercatinib. The approach has been confirmed to be linear, accurate, precise, robust, and has established limits of detection and quantitation. The established procedure was uncomplicated, cost-effective, and suitable for the routine analysis of selpercatinib in capsule dosage form.

Keywords: Selpercatinib, RP-HPLC and Validation.

Keywords:

Selpercatinib, RP-HPLC, Method development, Validation

DOI

https://doi.org/10.22270/jddt.v14i7.6702

Author Biographies

Paka Ramya, Department of Pharmaceutical Chemistry, Geethanjali College of Pharmacy, Cheeryal (V), Keesara (M), Medchal (D), Hyderabad-501301.

Department of Pharmaceutical Chemistry, Geethanjali College of Pharmacy, Cheeryal (V), Keesara (M), Medchal (D), Hyderabad-501301.

Medidi Srinivas, Department of Pharmaceutical Chemistry, Geethanjali College of Pharmacy, Cheeryal (V), Keesara (M), Medchal (D), Hyderabad-501301.

Department of Pharmaceutical Chemistry, Geethanjali College of Pharmacy, Cheeryal (V), Keesara (M), Medchal (D), Hyderabad-501301.

Bula Udaya Kumari, DSK Biopharma Inc, 112 Nova Dr, Morrisville, NC 27560, USA.

Department of R&D, DSK Biopharma Inc, 112 Nova Dr, Morrisville, NC 27560, USA.

References

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Sai KE, Srinivas M, Kumari BU, Sumalatha C, Madhavi A. Development and Validation of an HPLC Method for the Determination of Lobeglitazone in Bulk and in Tablet Formulation. International Journal of Pharmaceutical Investigation. 2024; 14(1). https://doi.org/10.5530/ijpi.14.1.26

Harshita D, Srinivas M, Kumari BU, Sumalatha C, Umadevi R. Establishment and Validation of a High-performance Liquid Chromatography Technique for Quantifying Dalbavancin in Injectable Formulations. Asian Journal of Pharmaceutical Research and Health Care. 2023; 15(4):385-92. https://doi.org/10.4103/ajprhc.ajprhc_112_23

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Published

15-07-2024
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How to Cite

1.
Ramya P, Srinivas M, Udaya Kumari B. Development of a Validated RP-HPLC/UV Method for the Quantitative Determination of Tyrosine Kinase RET Inhibitor: Selpercatinib in Capsule Formulation. J. Drug Delivery Ther. [Internet]. 2024 Jul. 15 [cited 2024 Dec. 6];14(7):57-63. Available from: https://jddtonline.info/index.php/jddt/article/view/6702

How to Cite

1.
Ramya P, Srinivas M, Udaya Kumari B. Development of a Validated RP-HPLC/UV Method for the Quantitative Determination of Tyrosine Kinase RET Inhibitor: Selpercatinib in Capsule Formulation. J. Drug Delivery Ther. [Internet]. 2024 Jul. 15 [cited 2024 Dec. 6];14(7):57-63. Available from: https://jddtonline.info/index.php/jddt/article/view/6702