Dexpanthenol Assay

This article is compiled based on the United States Pharmacopeia (USP) – 2025 Edition
Issued and maintained by the United States Pharmacopeial Convention (USP)
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1 INTRODUCTION

The following liquid chromatographic procedure is provided for the determination of Dexpanthenol as a component in dietary supplements or pharmaceutical dosage forms.

While conducting this procedure, protect solutions containing and derived from the test specimen and the Reference Standards from the atmosphere and light, preferably with the use of low-actinic glassware. Use the appropriate USP Reference Standards.

2 ASSAY

2.1 CHROMATOGRAPHIC METHODS, PROCEDURE 1

This procedure can be used to determine dexpanthenol in:

Oil-and Water-Soluble Vitamins Oral Solution

Oil- and Water Soluble Vitamins with Minerals Oral Solution

Water-Soluble Vitamins with Minerals Oral Solution

Unless specified in the monograph, the Standard solution, System suitability solution, and Sample solution are prepared as follows.

Mobile phase: 0.2 M monobasic sodium phosphate and methanol (97:3). Adjust with 1.7 M phosphoric acid to a pH of 3.2 ± 0.1.

Standard solution: 80 µg/ml, of USP Dexpanthenol RS in Mobile phase

System suitability solution: 80 µg/mL of USP Calcium Pantothenate RS in Mobile phase. Mix the resulting solution and Standard solution (1:1).

Sample solution: Equivalent to 80 µg/mL of dexpanthenol from Oral Solution in Mobile phase

2.1.1 Chromatographic system

(See Chromatography (621), System Suitability.)

Mode: LC

Detector: UV 210 nm

Column: 4.0-mm x 10-cm; packing 11

Flow rate: 1 mL/min

Injection volume: 20 µl.

2.1.2 System suitability

Samples: Standard solution and System suitability solution

Suitability requirements

Resolution: NLT 1.5 between dexpanthenol and calcium pantothenate, System suitability solution

Tailing factor: NMT 2.0 for the dexpanthenol peak, Standard solution

Relative standard deviation: NMT 2.0%, Standard solution

2.1.3 Analysis

Samples: Standard solution and Sample solution

Calculate the percentage of the labeled amount of dexpanthenol (C₉H₁₉NO₄) in the portion of the sample taken:

Result = (r_U/r_S)/(C_S/C_U) ×100

r_U = peak response of dexpanthenol from the Sample solution

r_S = peak response of dexpanthenol from the Standard solution

C_S = concentration of USP Dexpanthenol RS in the Standard solution (mg/mL)

C_S = nominal concentration of dexpanthenol in the Sample solution (mg/mL)

3 ADDITIONAL REQUIREMENTS

USP REFERENCE STANDARDS (11)

USP Calcium Pantothenate RS

USP Dexpanthenol RS