Stability-Indicating Validated HPLC Method for Analysis of Berberine Hydrochloride and Trimethoprim in Pharmaceutical Dosage Form

الملخص EN

A stability-indicating HPLC method was developed and validated for the determination of berberine hydrochloride and trimethoprim in pharmaceutical dosage form in the presence of degradation products.

The proposed RP-HPLC method utilizes an Agilent TC-C18, 4.6 mm × 250 mm, 5 μm, column using a mobile phase consisting of acetonitrile-50 mM potassium dihydrogen phosphate (30 : 70, v/v, pH adjusted to 3 with orthophosphoric acid) at a flow rate of 1.0 mL/min and UV detection at 271 nm.

The linearity of berberine hydrochloride and trimethoprim was in the range of 2 to 60 μg/mL (r=0.9996) and 1 to 30 μg/mL (r=0.9995), respectively.

Repeatability and intermediate precisions were also determined with percentage relative standard deviation (% RSD) less than 2.0%.

The limits of detection were found to be 9.8 ng/mL for berberine hydrochloride and 2.5 ng/mL for trimethoprim.

The mean recoveries for berberine hydrochloride and trimethoprim were 99.8 and 98.8%, respectively.

The stability of the two drugs was determined under different conditions and the proposed method has shown effective separation for their degradation products.

And the proposed assays method can thus be considered stability-indicating.