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 77
- Downloads 0
HOMOCASTASTERONE: A NOVEL PLANT KETOSTEROID INDUCING HAEMATOLOGICAL CHANGES IN NORMAL AND DIABETIC MALE RAT
Objective: To study the effect of brassinosteroid keto isoform homocastasterone, in diabetic male wistar rat as an antihyperglycemic factor and to evaluate its effects on the hemodynamic parameters in rat blood.Methods:...
Cost Analysis of Antihypertensive Agents in Rural Population: A Prospective Study
Objective: To calculate the direct medical and non-medical cost, indirect non-medical cost of prescription involved in the treatment of hypertension in rural inpatients at tertiary care teaching hospital.Methods: A cross...
SURVIVAL ANALYSIS FOR THE RISK OF DEVELOPING HEART ATTACK
Heart disease is the leading cause of death among Filipinos, accounting for 1 out of every 5 deaths in the past year. Each year, 170,000 Filipinos die from cardiovascular diseases, up from 85,000 more than 20 y ago. This...
THE CORRELATION BETWEEN FRAMINGHAM RISK SCORE AND THE CLINICAL AND BIOCHEMICAL PARAMETERS THAT MEASURE FUNCTIONAL DISABILITY AND DISEASE ACTIVITY IN IRAQI PATIENTS WITH RHEUMATOID ARTHRITIS
Objective: Rheumatoid arthritis (RA) patients have increased morbidity and mortality from premature cardiovascular (CV) disease (CVD). Framingham risk score (FRS) is a simplified coronary prediction tool developed to ena...
DRUG UTILIZATION STUDY OF ANTIPSYCHOTICS AND ITS COMMON ADR’S IN THE PSYCHIATRY OPD OF OHRC
ObjectiveTo determine the safety and efficacy of the drug used.To analyze drug utilization pattern.To identify the ADR’s caused by psychotropic drugsMethods: IRB approval was obtained and a hospital based cross section...