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Current Pharmaceutical Analysis

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ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

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Research Article

Isocratic RP-HPLC Method Development, Validation, and Optimization of BCS-II in Bulk and Dosage Form

Author(s): Uditi Handa*, Anuj Malik*, Kumar Guarve, Fatimah Jan and Kajal Nagpal

Volume 20, Issue 1, 2024

Published on: 25 January, 2024

Page: [37 - 45] Pages: 9

DOI: 10.2174/0115734129283491240103071614

Price: $65

Abstract

Background: Previous studies of dextromethorphan hydrobromide basically worked on simultaneous research with other compounds. So, the development of a novel method using the isocratic elution mode is needed.

Objective: For the detection of dextromethorphan hydrobromide (DXM) in diverse matrices, a straightforward, accurate, and sensitive reversed-phase HPLC technique using a Waters 2487 Dual λ Absorbance detector has been designed and validated.

Methods: In this experimental work, utilizing methanol/pH 3.0 potassium dihydrogen phosphate buffer (70:30, v/v) as the mobile phase, the separation was completed in 7 minutes on a C-18 HPLC column (4.6 cm length, 4.6 mm internal diameter; 5 μm particle size) utilizing an isocratic elution mode, flow rate of 1.0 mL/min, and UV-detection at 278 nm. Integration of the chromatography response was carried out using Empower 2.4 software.

Results: With an R2 of 0.9987, the current approach showed high linearity for DXM in the 10- 60 ppm range (retention time 4.281 ± 0.505 min). For DXM Hbr, the limits of detection (LOD & LOQ) were 10.633 μg/mL and 32.221μg/mL, respectively. Samples remained stable in the presence of the matrices without any apparent influence.

Conclusion: The novel approach, which used a straightforward liquid/liquid extraction procedure with recovery ranging from 100 ± 10 % performed by two different analytes, was accurate. The precision within and between days was ≤ 2.0% (RSD). The technique was proven to be reliable and repeatable, and it can be utilized with pharmacological (active ingredients, syrups) and also for biological (blood) matrices which can be used in future research work for bioanalytical method development such as pharmacokinetics studies.

Keywords: Dextromethorphan hydrobromide, isocratic RP-HPLC, system peaks, optimization, system suitability, method validation.

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