Exploring Densitometric Coupled With Spectrophotometric Analytical Approaches For Nucleotide Active Analogue For Retinitis Infection: In-Situ Measurement In Injection
Abstract
For the analysis of cidofovir in bulk and in custom injection formulations, new, affordable, quick, and effective HPTLC and UV-spectrophotometry area under curve (UV-AUC) procedures were created and validated. The analysis was performed using (10 x 10 cm) aluminium sheets precoated with silica gel 60-F254 (E. Merck) as the stationary phase and dichloromethane, methanol, and triethylamine (3:2:0.5 v/v/v) as the mobile phase. Cidofovir was quantitated by NP-HPTLC using UV detection at 273 nm. Quantitation using the HPTLC technique was done at concentrations between 500 - 3000 ng/band. Cidofovir produced a compact and distinct band with a retardation factor (Rf) of 0.45 ±0.02 using the HPTLC technique. The calibration of the HPTLC method using linear regression analysis showed a satisfactory linear relationship with a regression coefficient of r2 = 0.995. SLS (0.03 w/v) was used as the solvent in the development of the UV-AUC method, and the area was calculated at a wavelength between 266.40 and 278.80 nm. The UV-AUC analysis was shown to have a r2 = 0.999 correlation coefficient. In a concentration range of 5–30 µg/mL, the newly developed UV-AUC technique showed a fine linear relationship for cidofovir. The designed methodologies were validated for precision, robustness, ruggedness, accuracy, and sensitivity in accordance with guidelines published by the International Conference on Harmonization (ICH). The developed procedures can be successfully applied to the study of cidofovir in in-house injection and bulk form because statistical analysis revealed them to be precise, robust, sensitive, and accurate.
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