Development and validation of UV spectrophotometric method for orbifloxacin assay and dissolution studies

Cazedey, Edith Cristina Laignier; Salgado, Hérida Regina Nunes

doi:10.1590/S1984-82502014000300003

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Articles • Braz. J. Pharm. Sci. 50 (3) • Jul-Sep 2014 • https://doi.org/10.1590/S1984-82502014000300003 linkcopy

Development and validation of UV spectrophotometric method for orbifloxacin assay and dissolution studies

Authorship SCIMAGO INSTITUTIONS RANKINGS

Abstract

New, simple and cost effective UV-spectrophotometric method was developed for the estimation of orbifloxacin in pharmaceutical formulation. Orbifloxacin was estimated at 290 nm in 0.5 M hydrochloric acid. Linearity range was found to be 1.0-6.0 μg mL^-1. The method was tested and validated for various parameters according to main guidelines. The proposed method was successfully applied for the determination of orbifloxacin in tablets. The results demonstrated that the procedure is accurate, precise and reproducible, while being simple, economical and less time consuming. It can be suitably applied for the estimation of orbifloxacin in routine quality control and dissolution studies.

Medicines/quality control; Medicines/dissolution; Orbifloxacin/determination; UV spectrophotometry/quantitative analysis/validation

Solvent	% extracted orbifloxacin*
Water	≈ 78
Ethanol	≈ 68
Ethanol: water (50:50, v/v)	≈ 87
Methanol	≈ 89
0.1 M HCl	≈ 90
0.5 MHCl	≈ 102
0.1 MNaOH	≈ 12

Solvent	Wavelength (λ_max ) (nm)	Absorption
Water	290	0.9934
Methanol	291	1.0313
0.1 MNaOH	288	1.4901
5% HOAc	290	1.1724
0.5 M HCl	290	1.1888

Parameter
*Optical characteristics*
Apparent molar absorptivity (L mol^-1 cm^-1)		4.33 x 10⁴
*Regression analysis*
Slope (S.E.^a)		0.1107 (0.0006)
Intercept (S.E.^a)		-0.0028 (0.0008)
Regression coefficient (r)		0.9999
Calculated F-value (critical F-value)^b		2215.15 (4.75)
*Validation Parameters*
Selectivity	F_cal(F_crit)^c	0.86 (5,05)
	t_cal(t_crit)^c	1.74 (1.81)
Linearity (μg mL^-1)		1.0-6.0
LOD (μg mL^-1)		0.04
LOQ (μg mL^-1)		0.12
Accuracy - recovery (RSD%)		99.77 (1.78)
Precision (RSD%)^d	Intraday	1.23
	Interday	1.31
Robustness - t_cal(t_crit)^c	290-289 nm	1.61 (2.18)
	290-291 nm	0.36 (2.18)

Method	Mean % drug related to label claim	RSD%	Mean % drug dissolved	RSD%^b
UV^a	100.74	0.66	96.84	3.14
HPLC²⁴	100.34	1.31	94.25	2.04

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Universidade de São Paulo, Faculdade de Ciências Farmacêuticas Av. Prof. Lineu Prestes, n. 580, 05508-000 S. Paulo/SP Brasil, Tel.: (55 11) 3091-3824 - São Paulo - SP - Brazil
E-mail: bjps@usp.br

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All solutions were sonicated for 30 minutes