A stability-indicating HPLC method for simultaneous determination of morphine and naltrexone

Area of Science:

• Analytical Chemistry
• Pharmaceutical Analysis

Background:

• Accurate quantification of morphine sulfate and naltrexone hydrochloride is crucial for pharmaceutical development and quality control.
• Existing analytical methods may lack the specificity or stability-indicating capabilities required for comprehensive product assessment.

Purpose of the Study:

• To develop and validate a stability-indicating reversed-phase High-Performance Liquid Chromatography (HPLC) method.
• To enable simultaneous determination of morphine sulfate and naltrexone hydrochloride in bulk, solid dosage forms, and in-vitro dissolution samples.

Main Methods:

• Utilized a perfectSil™ MZ C18 column with an isocratic mobile phase of acetate buffer and acetonitrile.
• Employed a photodiode array detector at 280nm with a column temperature of 30°C for quantification.
• Assessed method specificity through forced degradation studies (thermal, peroxide, acid, base, photolytic) and biological fluid spiking.

Main Results:

• The developed HPLC method demonstrated specificity, with peak homogeneity confirmed under various stress conditions.
• The method was successfully validated for system suitability, linearity, accuracy, precision, detection/quantification limits, and robustness.
• Acceptable linearity ranges were established: 2-250 μg/mL for morphine and 4-100 μg/mL for naltrexone.

Conclusions:

• The validated stability-indicating HPLC method is suitable for the simultaneous determination of morphine sulfate and naltrexone hydrochloride.
• This analytical method effectively supports product development and quality control initiatives for these pharmaceutical compounds.