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Validated Stability-Indicating RP-HPLC Method for Daclatasvir in Tablets.

Hemlata M Nimje¹, Smita J Pawar¹, Meenakshi N Deodhar²

¹Pune District Education Association's Seth Govind Raghunath Sable College of Pharmacy, Department of Pharmaceutical Chemistry, Pune, India.

Turkish Journal of Pharmaceutical Sciences

|August 22, 2023

Summary

A new, validated RP-HPLC method precisely measures daclatasvir (DCV) and its stability. The method successfully identified DCV degradants under acidic, basic, and oxidative stress conditions, ensuring drug quality.

Keywords:

Daclatasvir RP-HPLC, tablets stability-indicating method validation

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Area of Science:

Analytical Chemistry
Pharmaceutical Analysis

Background:

Daclatasvir (DCV) is a crucial direct-acting antiviral medication.
Ensuring the stability and quality of pharmaceutical formulations is paramount for patient safety and therapeutic efficacy.

Purpose of the Study:

To develop and validate a precise and sensitive reverse-phase high-performance liquid chromatography (RP-HPLC) method for daclatasvir (DCV) analysis.
To evaluate the stability-indicating capabilities of the developed method by assessing DCV degradation under various stress conditions.

Main Methods:

RP-HPLC analysis was performed using an Agilent 1100 system with a C18 column.
A mobile phase of acetonitrile: 0.05% o-phosphoric acid (50:50 v/v) was used with a flow rate of 0.7 mL/min and detection at 315 nm.
Method validation included linearity, accuracy, precision, LOD, LOQ, and robustness according to ICH guidelines.

Main Results:

The validated RP-HPLC method demonstrated satisfactory performance for DCV analysis.
DCV exhibited degradation under acidic, basic, and oxidative stress conditions, with identified degradants and their retention times.
No significant degradation was observed under neutral or photolytic conditions, indicating method specificity.

Conclusions:

The developed RP-HPLC method is precise, sensitive, and stability-indicating for daclatasvir.
The method facilitates the identification of DCV degradants, aiding in understanding degradation pathways and ensuring drug product quality.