Quantitative determination of dexamethasone sodium phosphate in bulk and pharmaceuticals at suitable pH values using the spectrophotometric method.

Autor: Al-Owaidi MF; Department of Pharmaceutical Chemistry, College of Pharmacy, University of Kerbala, Kerbala, Iraq., Alkhafaji SL; Department of Pharmaceutical Chemistry, College of Pharmacy, University of Kerbala, Kerbala, Iraq., Mahood AM; Department of Pharmaceutical Chemistry, College of Pharmacy, University of Kerbala, Kerbala, Iraq.
Jazyk: angličtina
Zdroj: Journal of advanced pharmaceutical technology & research [J Adv Pharm Technol Res] 2021 Oct-Dec; Vol. 12 (4), pp. 378-383. Date of Electronic Publication: 2021 Oct 20.
DOI: 10.4103/japtr.japtr_6_21
Abstrakt: Dexamethasone sodium phosphate (DSP) is an ester of dexamethasone with anti-inflammatory action. This study provides new insights to develop a simple, precise, and accurate spectrophotometric method for the quantitative determination of DSP in bulk and pharmaceuticals. The method was validated before being applied to determine the DSP in six pharmaceutical injection forms from different companies. DSP is soluble in phosphate buffer, so it was used as a solvent, and a pH of 6 was found to be suitable for determination purposes. The DSP solution was scanned in the ultraviolet range (200-400 nm) using a double-beam spectrophotometer with a 1-cm quartz cell. The wavelength (λ max) of DSP was set at 242.5 nm, following the Beer-Lambert law for concentrations from 2 to 50 μg/ml. Dexa AIWA (Germany) showed the best results, being very close to the bulk value with no significant variation. Similarly, Dexamed (Cyprus) and HEMAZON (Syria) showed no significant differences from the bulk; however, the three remaining injections, DEXAKAL (India), DEXABRU (India), and DEXARON (China), showed significant variations from the bulk. Estimated limit of detection and limit of quantitation values for DSP were 0.83 and 2.5 μg/ml, respectively, with a regression coefficient of 0.999. Recovery studies were then used to determine the accuracy of the suggested method. The percentage of recovery was found to be 98.58%-102.52%. All results are suggesting a pivotal method for the routine analysis of DSP both in pure form and the commercially pharmaceutical forms.
Competing Interests: There are no conflicts of interest.
(Copyright: © 2021 Journal of Advanced Pharmaceutical Technology & Research.)
Databáze: MEDLINE