SIMULTANEOUS DETERMINATION OF NAPROXEN SODIUM AND ACETAMINOPHEN IN FIXED-DOSE COMBINATIONS FORMULATIONS BY FIRST-ORDER DERIVATIVE SPECTROSCOPY: APPLICATION TO DISSOLUTION STUDIES
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2015, Vol 7, Issue 5
Abstract
Objective: To validate and apply a new and easy zero-crossing derivative method for the simultaneous determination of naproxen sodium and acetaminophen in fixed-dose combinations formulations.Methods: Measurement was achieved using the first-derivative (1D) signals at 243.42 nm for naproxen sodium and at 297.10 nm for acetaminophen. The method was validated according to International Conference on Harmonization (ICH) guidelines and was used to obtain the dissolution profiles (USP Apparatus 2, 75 rpm and 900 ml of 0.1 M phosphate buffer pH 7.4) of five generic products and the reference product Febrax® (275/300 mg of naproxen sodium and acetaminophen, respectively). Dissolution data: percent of drug dissolved at 60 min, mean dissolution time (MDT) and dissolution efficiency (DE) were compared by a univariate one-way analysis of variance (ANOVA) followed by Dunnett’s multiple comparisons test. Differences were considered significant if *P<0.05. Additionally, data were adjusted to different kinetic models.Results: The method was linear (R2>0.99, *P<0.05) in the range of 10–50 µg/ml and 100–300 µg/ml for naproxen sodium and acetaminophen, respectively. The within-day and between-day precision and accuracy were within the acceptable criteria (relative standard deviation (RSD)<3% and 100±3%). Significant differences in MDT and DE values from all studies products were found (*P<0.05). All dissolution profiles were adjusted to Weibull’s kinetics and significant differences in Td values were found (*P<0.05).Conclusion: The proposed derivative spectrophotometry method can be used for the simultaneous determination of naproxen sodium and acetaminophen in dissolution studies. The method is rapid, simple, accurate, and precise without the need of high cost investment.Â
Authors and Affiliations
JosÉ RaÚl Medina, Carlos Alfonso LÓpez-tableros, Gerardo HernÃndez Altamirano, Georgina AlarcÓn Ãngeles, Marcela Hurtado, Adriana Miriam DomÃnguez-ramÃrez
Keywords
Related Articles
- EP ID EP578804
- DOI -
- Views 75
- Downloads 0
CLINICAL INTERVENTIONS UNDERTAKEN BY FINAL YEAR STUDENT PHARMACISTS ON ROUNDING TEAMS IN NIGERIA: A 3-YEAR CROSS-SECTIONAL EVALUATION
Objective: The aim of this study was to assess the interventions of final year pharmacy students of University of Nigeria Nsukka (UNN) during clinical ward rounds in a secondary and a tertiary hospital in Enugu State, Ni...
APPLICATION OF MODIFIED USP APPARATUS I AND IN SITU FIBER OPTIC ANALYSIS FOR DRUG RELEASE FROM IBUPROFEN NANOSPHERES
Objective: The main objective of this study was to ascertain the applicability of the modified USP Apparatus I and in situ fiber optic UV analysis for in vitro release testing of ibuprofen (model drug) nanospheres (IbNS)...
STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF CLEVIDIPINE BUTYRATE IN SYNTHETIC MIXTURE
Objective: To develop and validate stability indicating HPTLC method for determination of clevidipine butyrate in synthetic mixture.Methods: The present study deals with development and validation of stability indicating...
ABSORPTION CORRECTION METHOD FOR THE SIMULTANEOUS ESTIMATION OF N-ACETYL-L-CYSTEINE AND AMBROXOL HYDROCHLORIDE IN BULK AND IN COMBINED TABLET DOSAGE FORM
Objective: The objective of this research was to estimate the concentrations of N-Acetyl-L-cysteine (NAC) and Ambroxol Hydrochloride (AMB) simultaneously, in bulk and combined tablet formulation using a new, simple, prec...
EFFECT OF CRUDE SULPHATED POLYSACCHARIDE FROM MARINE BROWN ALGAE IN TPA INDUCED INFLAMMATION ON POLY MORPHONUCLEAR LEUKOCYTES
Objective: The present study aims to evaluate the anti-inflammatory activity of crude sulphated polysaccharide from marine brown algae sargassum ilicifoliumMethods: The present study involves the investigation of crude s...