Development and Validation of a simple UV spectrophotometric method for the determination of Delamanid

Vaishali Pardeshi; Tushar Lokhande; Rina Firke; Sneha Patil; Vishakha Pawar

doi:10.26452/ijrps.v14i1.4176

Vaishali Pardeshi ⁽¹⁾ , Tushar Lokhande ⁽²⁾ , Rina Firke ⁽³⁾ , Sneha Patil ⁽⁴⁾ , Vishakha Pawar ⁽⁵⁾

(1) Department of Pharmaceutical Chemistry, Mahatma Gandhi Vidyamandir’s Pharmacy College, Nashik, Maharashtra, India, India ,

(2) Department of Pharmaceutical Chemistry, Mahatma Gandhi Vidyamandir’s Pharmacy College, Nashik, Maharashtra, India, India ,

(3) Department of Pharmaceutical Chemistry, Mahatma Gandhi Vidyamandir’s Pharmacy College, Nashik, Maharashtra, India, India ,

(4) Department of Pharmaceutical Chemistry, Mahatma Gandhi Vidyamandir’s Pharmacy College, Nashik, Maharashtra, India, India ,

(5) Department of Pharmaceutical Chemistry, Mahatma Gandhi Vidyamandir’s Pharmacy College, Nashik, Maharashtra, India, India

https://doi.org/10.26452/ijrps.v14i1.4176

Issue
Vol. 14 No. 1 (2023): Volume 14 Issue 1

Keywords:

Delamanid, UV Spectrophotometric Method, Process Validation, ICH Guidelines

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Abstract

Using a Shimadzu UV-2600, a quick, precise, easy, and affordable UV spectrophotometric approach has been created. Solvent made with methanol to assess the bulk Delamanid content. A wavelength of 320 nm was used for the detection process. The parameters linearity, accuracy, precision, ruggedness, robustness, LOD, and LOQ were taken into consideration during method validation in accordance with ICH Q2R1 criteria. It demonstrated linearity in the range of 60-360 (/mL) at a predetermined λmax of 320 nm, and it had a strong correlation coefficient (R2-0.996) and outstanding mean recovery (99.00-100.07%). Determination of Delamanid used this technique effectively. The method's linearity, accuracy, repeatability, and reproducibility were statistically and by recovery experiments confirmed. The outcomes demonstrated the method's applicability for both regular Delamanid bulk analysis and commercial formulations.

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