Green micellar liquid chromatographic method for simultaneous determination of antihistaminic drugs tripelennamine hydrochloride and diphenhydramine in pharmaceutical gel.

A new green micellar liquid chromatographic method has been developed and validated for the simultaneous determination of diphenhydramine (DPH) and tripelennamine hydrochloride (TRP) using a micellar mobile phase consisting of 1 mM Tween 20 in phosphate buffer pH 4:isopropanol (85:15, %v/v). The method was linear in the range of 4-150 and 5-120 µg/mL for TRP and DPH, respectively. The method was successfully applied for the simultaneous determination of DPH and TRP in a laboratory-prepared gel containing all possible excipients with mean percent recoveries ± standard deviation of 100.346 ± 1.265 and 100.754 ± 1.117 for TRP and DPH, respectively. The method was validated according to the International Conference on Harmonization guidelines. The method is confirmed to have excellent greenness.

Enhanced fluorimetric detection of diphenylpyraline HCl using micelle and cyclodextrin mediated approach: Spectrofluorimetric and micellar liquid chromatographic application for either single or combined formulation with caffeine and paracetamol.

Highly sensitive micellar spectrofluorimetric method (Method I) has been developed and validated for the determination of diphenylpyraline HCl in pharmaceutical tablets and in plasma. Sodium dodecyl sulfate improves the intensity of fluorescence of diphenylpyraline at 286 nm at pH 5 that allow its determination in plasma at nano-level. the mean percent recovery ± S.D was 99.719 ± 0.338 in plasma. In addition, Green cyclodextrin-modified micellar liquid chromatographic method (Method II) has been developed and validated for simultaneous determination of diphenylpyraline, paracetamol and caffeine using cyclodextrin micellar mobile phase consisted of 30 mM Brij*35, 0.5 mM hydroxypropyl ß-cyclodextrin and phosphate buffer pH 4: MeOH (95:5, %v/v) that allows their simultaneous determination with enhanced spectrofluorimetric detection of diphenylpyraline. Method II was effectively applied for the simultaneous determination of diphenylpyraline, paracetamol and caffeine in a ternary laboratory prepared mixture which contained all possible excipients with mean percent recoveries ± S.D of 100.176 ± 1.008, 101.166 ± 0.415 and 100.708 ± 1.836, respectively. Linearity range for Method I was 0.1-1 µg. mL-1 for diphenylpyraline and for Method II was 0.3-50, 25-350, and 0.5-50 for caffeine, paracetamol and diphenylpyraline, respectively. Method I was also applied in spiked human plasma with linearity range 0.2-0.5 µg. mL-1. The methods are verified to have excellent greenness.

Micelle-enhanced spectrofluorimetric determination of diphenhydramine: application to human plasma and its simultaneous determination with naproxen in pharmaceutical tablets.

Two simple and sensitive spectrofluorimetric methods were developed and validated for determination of diphenhydramine. The use of sodium dodecyl sulfate surfactant at pH 7 enhances the fluorescence intensity of diphenhydramine at 286 nm (method I) enabling its nanodetermination in biological samples with mean per cent recovery ± SD of 100.33 ± 1.519. Method I was validated according to ICH-Q2R1 guidelines and was successfully applied for determination of diphenhydramine in pharmaceutical dosage form and spiked human plasma in the concentration ranges 0.1-4.0 µg/mL and 0.2-1.0 µg/mL, respectively. Method I acted as a basis for the development of a first derivative synchronous spectrofluorimetry (method II) for simultaneous analysis of diphenhydramine and naproxen using a zero-crossing approach. Method II determines both drugs with linearity ranges of 0.05-3.0 µg/mL and 0.1-0.9 µg/mL for diphenhydramine and naproxen, respectively. The developed method was applied for the simultaneous determination of both drugs in their laboratory-prepared mixtures containing all expected excipients. Method II determines both drugs with a mean percent recovery ± SD of 100.56 ± 0.891 and 100.20 ± 1.125 for diphenhydramine and naproxen, respectively. The method was statistically compared with a reported method using Student's t- and F- tests, and no significant differences were observed.