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2024, Vol: 2, Issue: 1
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Original Article
Online Published: 18 Dec 2024
 


DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SETMELANOTIDE UTILIZING QBD PRINCIPLES

Saidatri Arige , Nataraj KS, LakshmanaRao A.


Abstract
Utilizing QbD, a precise and innovative RP-HPLC technique was developed for Setmelanotide quantification. Design of Experiments (DOE) facilitated multivariate optimization, exploring the interplay between responses and independent variables through a polynomial equation. This optimization, aided by Design Expert software and Central Composite Design, finely adjusted Critical Method Parameters (CMPs). Chromatographic separation was executed on the X-Bridge C18 column measures 150 mm in length and 4.6 mm in diameter, featuring a particle size of 3.5 µm at 30°C. Optimized parameters comprised a mobile phase of 60 portions 0.1% Ortho phosphoric acid (OPA) & 40 portions of acetonitrile in volume/volume proportion at pH 3, achieving a desirability score of one. Detection at 225 nm with a flow rate of 0.8 ml/min disclosed a retention time of 2.271 minutes. Method validation aligned with ICH Q2(R1) guidelines, confirming the statistical significance of the chosen model via ANOVA (p=0.05). Two-dimensional contour plots effectively illustrated factor impacts and interactions on responses. Validation encompassed a comparison of actual and predicted values, all within acceptable ranges.

Key words: Setmelanotide, DoE Approach, Central Composite design, and ICH Q2 (R1)


 
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Pubmed Style

SA, KS N, A L, . DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SETMELANOTIDE UTILIZING QBD PRINCIPLES. Eu J Sci Res Rev. 2024; 2(1): 9-22. doi:10.5455/EJSRR.20241017032752

Web Style

SA, KS N, A L, . DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SETMELANOTIDE UTILIZING QBD PRINCIPLES. https://www.wisdomgale.com/ejsrr/?mno=224902 [Access: December 28, 2024]. doi:10.5455/EJSRR.20241017032752

AMA (American Medical Association) Style

SA, KS N, A L, . DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SETMELANOTIDE UTILIZING QBD PRINCIPLES. Eu J Sci Res Rev. 2024; 2(1): 9-22. doi:10.5455/EJSRR.20241017032752


Vancouver/ICMJE Style

SA, KS N, A L, . DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SETMELANOTIDE UTILIZING QBD PRINCIPLES. Eu J Sci Res Rev. (2024), [cited December 28, 2024]; 2(1): 9-22. doi:10.5455/EJSRR.20241017032752


Harvard Style

, S. A., KS, N., A, L. & (2024) DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SETMELANOTIDE UTILIZING QBD PRINCIPLES. Eu J Sci Res Rev, 2 (1), 9-22. doi:10.5455/EJSRR.20241017032752


Turabian Style

, Saidatri Arige, Nataraj KS, LakshmanaRao A, and . 2024. DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SETMELANOTIDE UTILIZING QBD PRINCIPLES. European Journal of Scientific Research and Reviews, 2 (1), 9-22. doi:10.5455/EJSRR.20241017032752


Chicago Style

, Saidatri Arige, Nataraj KS, LakshmanaRao A, and . "DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SETMELANOTIDE UTILIZING QBD PRINCIPLES." European Journal of Scientific Research and Reviews 2 (2024), 9-22. doi:10.5455/EJSRR.20241017032752


MLA (The Modern Language Association) Style

, Saidatri Arige, Nataraj KS, LakshmanaRao A, and . "DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SETMELANOTIDE UTILIZING QBD PRINCIPLES." European Journal of Scientific Research and Reviews 2.1 (2024), 9-22. Print. doi:10.5455/EJSRR.20241017032752


APA (American Psychological Association) Style

, S. A., KS, N., A, L. & (2024) DEVELOPMENT AND VALIDATION OF AN RP-HPLC METHOD FOR QUANTITATIVE ANALYSIS OF SETMELANOTIDE UTILIZING QBD PRINCIPLES. European Journal of Scientific Research and Reviews, 2 (1), 9-22. doi:10.5455/EJSRR.20241017032752


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