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Tropical Journal of Pharmaceutical Research
Pharmacotherapy Group, Faculty of Pharmacy, University of Benin, Benin City, Nigeria
ISSN: 1596-5996
EISSN: 1596-9827
Vol. 14, No. 11, 2015, pp. 2061-2069
Bioline Code: pr15270
Full paper language: English
Document type: Research Article
Document available free of charge

Tropical Journal of Pharmaceutical Research, Vol. 14, No. 11, 2015, pp. 2061-2069

 en In vitro Evaluation of Trimethoprim and Sulfamethoxazole from Fixed-Dose Combination Generic Drugs using Spectrophotometry: Comparison of Flow-Through Cell and USP Paddle Methods
Medina, Raúl; Miranda, Maximiliano; Hurtado, Marcela; Domínguez- Ramírez, Adriana M.; Reyes, Octavio & Ruiz-Segura, Juan C.

Abstract

Purpose: To develop a first-order derivative spectrophotometric method for the determination of trimethoprim (TMP) and sulfamethoxazole (SMX) from fixed-dose combination generic products using a flow-through cell technique.
Methods: Absorbance measurement was achieved at 247.8 and 257.9 nm for trimethoprim and sulfamethoxazole, respectively. USP Apparatus 4 with 22.6 mm cells, laminar flow at 16 ml/min, and 0.1 N HCl at 37 °C as dissolution medium, were used. Dissolution profiles were compared with modeldependent and independent methods.
Results: All the products met the pharmacopeial dissolution criterion (Q ≥ 70 %, at 60 min), except SMX in two products (SC 400 mg and SB1 800 mg) using the flow-through cell (53.62 and 49.74 % dissolved, respectively). Using both USP apparatuses, significant differences in mean dissolution time and dissolution efficiency values were found (p < 0.05). All products were in line with Weibull’s kinetics and significant differences in derived parameters (Td) values were found (p < 0.05).
Conclusion: Determination of TMP and SMX by derivative spectrophotometry can easily be employed for dissolution studies using the flow-through cell technique. However, it would be necessary to determine correlation with in-vivo test results in order to assure safe interchangeability.

Keywords
Trimethoprim; Sulfamethoxazole; Flow-through cell method; First-order derivative spectrophotometry; Fixed-dose combination generic drugs

 
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