Development and Validation of HPLC Method for Quantification of Daclatasvir in Pure and Solid Dosage Form

Saeed, Nida; Afridi, Muhammad Shaharyar Khan; Latif, Abida; Fahham, Hafiz Hanzalah; Aslam, Itzaz; Mazhar, Muhammad; Afridi, Muhammad Shahbaz Khan

doi:10.21608/ejchem.2021.80600.3994

Development and Validation of HPLC Method for Quantification of Daclatasvir in Pure and Solid Dosage Form

Document Type : Original Article

Authors

¹ Punjab University College of Pharmacy, University of the Punjab

² H#2, St.#1 Behind Old Ice Factory Fateh Garh Road Gulshan Park Lalpul Mughalpura

³ Department of Pharmacy, University of Karachi, Karachi – 75270, Pakistan

10.21608/ejchem.2021.80600.3994

Abstract

Daclatasvir is a novel and highly selective NS5A replication inhibitor of HCV. It is stated to offer the potential for interferon free treatment when used in combination with another direct acting antivirals. The current project is aimed to develop and validate an easy to perform, precise, fast and accurate reverse phase HPLC method for Daclatasvir in the solid dosage form by wielding UV detector, in accordance with ICH Q2 (R1) guidelines. The process was carried out for daclatasvir, utilizing C-18 column (25 cm length, 4.6 mm internal diameter, and 5 µm particle size) in isocratic mode, with mobile phase comprising of acetonitrile and phosphate buffer (40:60 v/v). The flow rate was 1 mL/min and the detection wavelength examined out by UV detector was 304 nm. The retention time for daclatasvir was 3.0 ± 0.1 min. RSD (0.65 %), theoretical plates (1118117) and tailing factor (1) complied within acceptable certified limits. The developed method showed the linearity within a range (1 – 5 µg/mL). The accuracy of the developed method was figured out by recovery analysis and it was 99 %. The precision analysis i.e. interday (0.0.790937 %), intraday (0.364517 %) and repeatability (0.229167 %), were within the acceptance criteria. All the validation parameters were within the acceptable limits. The sample solutions of daclatasvir tablets (Dacriva, 60 mg) developed and correlated its chromatograms with working standard solution and perceived the percentage purity of daclatasvir in the tablet, found within recommended acceptable limit (90 – 110 %). It is concluded that the HPLC method is sensitive, stable, rapid and reliable. It can be deployed for the quantification of daclatasvir of standard and brands available in market in the solid dosage form in the pharmaceutical industry.

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