Publisher: Pharmacotherapy Group

In Vitro Evaluation of Trimethoprim and Sulfamethoxazole From Fixed-Dose Combination Generic Drugs Using Spectrophotometry: Comparison of Flow-Through Cell and Usp Paddle Methods

Raúl Medina, Maximiliano Miranda, Marcela Hurtado, Adriana M. Domínguez- Ramírez, Octavio Reyes, Juan C Ruiz-segura
KEYWORDS: Trimethoprim, Sulfamethoxazole, Flow-through cell method, First-order derivative spectrophotometry, Fixed-dose combination generic drugs

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.



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