title: Comparative study between recent methods manipulating ratio spectra and classical methods based on two-wavelength selection for the determination of binary mixture of antazoline hydrochloride and tetryzoline hydrochloride.
abstract: A comparative study was developed between two classical spectrophotometric methods (dual wavelength method and Vierordt's method) and two recent methods manipulating ratio spectra (ratio difference method and first derivative of ratio spectra method) for simultaneous determination of Antazoline hydrochloride (AN) and Tetryzoline hydrochloride (TZ) in their combined pharmaceutical formulation and in the presence of benzalkonium chloride as a preservative without preliminary separation. The dual wavelength method depends on choosing two wavelengths for each drug in a way so that the difference in absorbance at those two wavelengths is zero for the other drug. While Vierordt's method, is based upon measuring the absorbance and the absorptivity values of the two drugs at their λ(max) (248.0 and 219.0 nm for AN and TZ, respectively), followed by substitution in the corresponding Vierordt's equation. Recent methods manipulating ratio spectra depend on either measuring the difference in amplitudes of ratio spectra between 255.5 and 269.5 nm for AN and 220.0 and 273.0 nm for TZ in case of ratio difference method or computing first derivative of the ratio spectra for each drug then measuring the peak amplitude at 250.0 nm for AN and at 224.0 nm for TZ in case of first derivative of ratio spectrophotometry. The specificity of the developed methods was investigated by analyzing different laboratory prepared mixtures of the two drugs. All methods were applied successfully for the determination of the selected drugs in their combined dosage form proving that the classical spectrophotometric methods can still be used successfully in analysis of binary mixture using minimal data manipulation rather than recent methods which require relatively more steps. Furthermore, validation of the proposed methods was performed according to ICH guidelines; accuracy, precision and repeatability are found to be within the acceptable limits. Statistical studies showed that the methods can be competitively applied in quality control laboratories.
authors.affiliation: National Organization for drug control and research (NODCAR), 6 Abu HazemStreet, Pyramids Ave, P.O. Box 29, Giza, Egypt. Electronic address: lamiasalam22@yahoo.com.
authors.forename: Lamia M
authors.initials: LM
authors.lastname: Abdel-Halim
authors.affiliation: Analytical Chemistry Department, Faculty of pharmacy, Cairo University, Kasr El-Aini Street, 11562, Cairo-Egypt.
authors.forename: Mohamed K
authors.initials: MK
authors.lastname: Abd-El Rahman
authors.affiliation: Analytical Chemistry Department, Faculty of pharmacy, Cairo University, Kasr El-Aini Street, 11562, Cairo-Egypt.
authors.forename: Nesrin K
authors.initials: NK
authors.lastname: Ramadan
authors.affiliation: National Organization for drug control and research (NODCAR), 6 Abu HazemStreet, Pyramids Ave, P.O. Box 29, Giza, Egypt.
authors.forename: Hoda F A
authors.initials: HF
authors.lastname: El Sanabary
authors.affiliation: Analytical Chemistry Department, Faculty of pharmacy, Cairo University, Kasr El-Aini Street, 11562, Cairo-Egypt.
authors.forename: Maissa Y
authors.initials: MY
authors.lastname: Salem
mesh_terms: D000865:Antazoline / Q000032:analysis*; D018926:Anti-Allergic Agents / Q000032:analysis*; D004338:Drug Combinations; D007093:Imidazoles / Q000032:analysis*; D014663:Nasal Decongestants / Q000032:analysis*; D011786:Quality Control; D013053:Spectrophotometry / Q000379:methods*
chemical_list: D018926:Anti-Allergic Agents; D004338:Drug Combinations; D007093:Imidazoles; D014663:Nasal Decongestants; D000865:Antazoline; C005810:tetrahydrozoline
keywords: Antazoline; Derivative ratio; Dual wavelength; Ratio difference; Tetryzoline; Vierordt's method