Quantification of doxycycline hyclate in tablets by HPLC-UV method

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Doxycycline hyclate is a widely used antibiotic.
• Accurate quantification is crucial for pharmaceutical quality control.

Purpose of the Study:

• To develop and validate a rapid and sensitive analytical method for doxycycline hyclate determination.
• To assess the method's suitability under various stress conditions.

Main Methods:

• Gradient reversed-phase high-performance liquid chromatography (RP-HPLC) was employed.
• A CN Luna column with a specific mobile phase (water + 0.1% TFA-acetonitrile + 0.1% TFA) was used.
• Ultraviolet detection at 360 nm and ambient temperature (25°C) were utilized.

Main Results:

• The method demonstrated linearity over a 50-100 µg/mL range (r = 0.9999).
• Limits of detection (LOD) and quantification (LOQ) were 2.83 µg/mL and 8.59 µg/mL, respectively.
• The method proved suitable despite degradation product interference under stress conditions, showing excellent recoveries in pharmaceutical samples.

Conclusions:

• The developed RP-HPLC method is accurate, sensitive, precise, and rapid for doxycycline hyclate analysis.
• This method is suitable for routine quality control of doxycycline hyclate in bulk drug and tablet formulations.