Validated spectrophotometric methods for simultaneous determination of troxerutin and carbazochrome in dosage form

• Troxerutin (TXN) is co-formulated with Carbazochrome (CZM).
• No method was reported for determination of TXN and CZM in their mixture form.
• Four spectrophotometric methods were developed for their simultaneous determination.
• The methods were validated according to the ICH guidelines.
• The results were statistically compared to the manufacturer’s method.

Four simple, accurate, sensitive and precise spectrophotometric methods were developed and validated for simultaneous determination of Troxerutin (TXN) and Carbazochrome (CZM) in their bulk powders, laboratory prepared mixtures and pharmaceutical dosage forms. Method A is first derivative spectrophotometry (D1) where TXN and CZM were determined at 294 and 483.5 nm, respectively. Method B is first derivative of ratio spectra (DD1) where the peak amplitude at 248 for TXN and 439 nm for CZM were used for their determination. Method C is ratio subtraction (RS); in which TXN was determined at its λmax (352 nm) in the presence of CZM which was determined by D1 at 483.5 nm. While, method D is mean centering of the ratio spectra (MCR) in which the mean centered values at 300 nm and 340.0 nm were used for the two drugs in a respective order. The two compounds were simultaneously determined in the concentration ranges of 5.00–50.00 μg mL−1 and 0.5–10.0 μg mL−1 for TXN and CZM, respectively. The methods were validated according to the ICH guidelines and the results were statistically compared to the manufacturer’s method.

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