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International Journal of Zoology and Applied Biosciences Research Article
Development and validation of a robust RP-HPLC method for the simultaneous quantification of lidocaine and hyaluronidase in pharmaceutical formulations
Sheik Karishma, Mahesh M, Kiran Jyothi R, Priyanka B
Year : 2026 | Volume: 11 | Issue: 4 | Pages: 40-49
Received on: 12/05/2026
Revised on: 22/05/2026
Accepted on: 18/06/2026
Published on: 01/07/2026
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Sheik Karishma, Mahesh M, Kiran Jyothi R, Priyanka B( 2026).
Development and validation of a robust RP-HPLC method for the simultaneous quantification of lidocaine and hyaluronidase in pharmaceutical formulations
. International Journal of Zoology and Applied Biosciences, 11( 4), 40-49.
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Abstract
A Simple and Robust Approach as a new development and validation, RP-HPLC method was established for simultaneous determination of lidocaine and hyaluronidase. Analytical separation was performed on C18 column (eg. Spursil C18-EP, 250 × 4.6 mm, 5 ?m) using mobile phase consisting of potassium dihydrogen phosphate buffer, pH 3.5: methanol (30:70, v/v) at flow rate of 1.0 mL/min. The detection was done at UV 254 nm. Retention time was found to be 2.264 min (lidocaine) and 3.032 min (hyaluronidase) within 8.0 min runtime. The tailing factors were 1.25 and 1.22, USP plate count was 3302 and 3232, respectively and resolution factor was found to be 6.2. Validation Parameters Aspects Validation criteria Lidocaine Hyaluronidase Specificity Method was specific for each component Linearity (0.1 to 0.5) 10-50 ppm, r2 = 0.999 5-25 ppm, r2 = 0.999 Precision (%RSD) 1.5% 0.6% Accuracy (%Recovery) 98-102%Robustness LOD 0.05 and 0.11 ppm LOQ 0.18 and 0.39 ppm The proposed method can be employed for routine quality control analysis of the combination formulations.
Keywords
RP-HPLC, Lidocaine, Hyaluronidase, Method validation, ICH guidelines, Pharmaceutical analysis.
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© The Author(s) 2025. This article is published by International Journal of Zoology and Applied Biosciences under the terms of the Creative Commons Attribution 4.0 International License (creativecommons.org), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
