Estimation of Measurement Uncertainty Using Top-Down and Bottom-Up Approaches for Accurate Content Determination of Meloxicam in Injectable Dosage Forms

Dino Karpicarov; Ivana Mitrevska; Paulina Apostolova; Marija Arev; Zorica Arsova Sarafinovska; Marija Darkovska Sarafimovska; Branka Dražić; Jasmina Tonic Ribarska; Biljana Gjorgjeska

doi:10.5937/arhfarm75-63142

Dino Karpicarov Goce Delcev University, Faculty of Medical Sciences, Stip, North Macedonia
Ivana Mitrevska Goce Delcev University, Faculty of Medical Sciences, Stip, North Macedonia
Paulina Apostolova Goce Delcev University, Faculty of Medical Sciences, Stip, North Macedonia
Marija Arev Goce Delcev University, Faculty of Medical Sciences, Stip, North Macedonia
Zorica Arsova Sarafinovska Goce Delcev University, Faculty of Medical Sciences, Stip, North Macedonia; Institute of Public Health of the Republic of North Macedonia, Skopje, North Macedonia
Marija Darkovska Sarafimovska Goce Delcev University, Faculty of Medical Sciences, Stip, North Macedonia
Branka Dražić University of Belgrade - Faculty of Pharmacy, Department of General and Inorganic Chemistry, Belgrade, Serbia
Jasmina Tonic Ribarska Institute of Applied Chemistry and Pharmaceutical Analysis, Faculty of Pharmacy, Ss. Cyril and Methodius University, Skopje, North Macedonia
Biljana Gjorgjeska Goce Delcev University, Faculty of Medical Sciences, Stip, North Macedonia

DOI: https://doi.org/10.5937/arhfarm75-63142

Keywords: bottom-up approach, meloxicam, measurement uncertainty, top-down approach

Abstract

Measurement uncertainty plays a critical role in ensuring the reliability, accuracy, and regulatory compliance of analytical results in pharmaceutical quality control. This study presents a comprehensive comparison of the Top-down and Bottom-up approaches for estimating the uncertainty associated with the quantitative determination of Meloxicam in injectable dosage forms using a validated HPLC method. The Top-down approach, based on method validation data, yielded an expanded uncertainty of ±0.336 mg per injection, while the Bottom-up approach (incorporating uncertainties from volumetric equipment, reference standards, and molar mass) produced a broader value of ±0.646 mg per injection. The results highlight the complementary nature of both approaches and support the integration of their respective strengths to improve the robustness of uncertainty estimation. The proposed methodology is applicable to other methods within pharmaceutical quality control.

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