Validated spectrophotometric methods for simultaneous determination of nebivolol hydrochloride and valsartan in their tablet

Autor: Aya A. Marie, Sherin F. Hammad, Amira H. Kamal
Rok vydání: 2020
Předmět:
Zdroj: Microchemical Journal. 155:104741
ISSN: 0026-265X
DOI: 10.1016/j.microc.2020.104741
Popis: Four simple spectrophotometric methods have been developed for the simultaneous determination of nebivolol (NEB) and valsartan (VAL) in bulk and in synthetic mixture simulated to tablet dosage form. Method (I) was area under curve (AUC) which based on the measurement of area between 246 and 256 nm for VAL and 273 and 283 nm for NEB. Method (II) applied the first derivative of ratio spectra (1DD) using VAL 40.0 µg/mL as divisor for determination of NEB, the amplitude of the peak at 294.5 nm was directly proportional to NEB concentration. NEB (30.0 µg/mL) was used as divisor for determination of VAL. The amplitude of peak at 253.4 nm was directly proportional to VAL concentration. Method (III) was the ratio difference (RD) method which based on the measurement of difference in amplitudes (∆P) in the ratio spectra; ∆P (291-275) was directly proportional to NEB concentration, and ∆P (239.2-301.5) was directly proportional to VAL concentration. Calibration curves of the three methods are linear over the concentration ranges of 2.0–80.0 µg/mL and 4.0–80.0 µg/mL for NEB and VAL, respectively. The mean percentage recovery ± SD values for tablet assay for NEB and VAL, respectively were found to be 100.59 ± 1.32 and 100.55 ± 1.12 using AUC, 100.02 ± 1.52 and 101.18 ± 0.42 using 1DD method, and finally 101.38 ± 1.88 and 101.24 ± 0.28 using RD method. Method (IV) involved multivariate spectrophotometric methods including classical least squares (CLS), principal component regression (PCR), and partial least squares (PLS) applied to the UV absorption spectra of the standard solutions containing both drugs recorded in the range of 272–282 nm at 1 nm intervals. Calibration was performed using training set consisting of ten binary mixture solutions in different combinations in range of 5.0–60.0 µg/mL NEB and 15.0–80.0 µg/mL VAL. The mean percentage recovery ± SD values for tablet assay for NEB and VAL, respectively were found to be 100.69 ± 1.54 and 100.90 ± 0.55 using CLS, 100.72 ± 1.54 and 100.89 ± 0.55 using PCR, and 100.72 ± 1.54 and 100.89 ± 0.55 using PLS. The four developed methods were validated and showed successful application to the simultaneous determination of NEB and VAL in their synthetic mixtures. ICH guidelines were used to validate the methods. F and t-tests were used for statistical comparison between the results obtained by the developed methods and those of the reported one. No significant difference was observed regarding both accuracy and precision.
Databáze: OpenAIRE
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