Development and Validation of a Stability-Indicating RP-HPLC Method for the Quantification of Daclatasvir in Tablet Formulation.

Authors

  • Himanshu
  • Suryakant Verma
  • Jaishiv
  • Kshitiz Sahu
  • Sameeksha
  • Anup Kumar Mamgain

Keywords:

Daclatasvir; RP-HPLC, Dissolution, Assay, Stability-indicating method, Method Development, Method validation, Pharmaceutical analysis, Antiviral

Abstract

A robust, stability-indicating reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantification of Daclatasvir in tablet formulations, employing separate methods for dissolution and assay determination. The dissolution method utilized an Inertsil C18 column (150 × 4.6 mm, 5 μm) with gradient elution comprising phosphate buffer (pH 2.5) and acetonitrile at a flow rate of 1.3 mL/min, with detection at 318 nm. Conversely, the assay method employed an isocratic elution using phosphate buffer (pH 7.0) and acetonitrile (60:40 v/v) on the same column at a flow rate of 1.5 mL/min. Both methods demonstrated excellent specificity, linearity (r² > 0.999), precision (%RSD < 2%), and accuracy within the acceptable recovery range of 98–102%. Forced degradation studies confirmed the methods’ capability to distinguish Daclatasvir from its degradation products, affirming their stability-indicating nature. The validated methods comply with ICH Q2 (R1) guidelines and are suitable for routine quality control and stability testing of Daclatasvir in pharmaceutical formulations, ensuring reliable assessment of both dissolution profiles and assay content....

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Published

2025-06-14

How to Cite

1.
Himanshu H, Verma S, Jaishiv J, Sahu K, Sameeksha S, Mamgain AK. Development and Validation of a Stability-Indicating RP-HPLC Method for the Quantification of Daclatasvir in Tablet Formulation. J Neonatal Surg [Internet]. 2025 Jun. 14 [cited 2026 Apr. 14];14(32S):9983-10003. Available from: https://jneonatalsurg.com/index.php/jns/article/view/9730

Issue

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

Section

Original Article

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