TITLE:
Stability Indicating Analytical Method Development and Validation for the Simultaneous Determination of Degradation Impurities of Buprenorphine and Naloxone in Combination Pharmaceutical Dosage Form by RP-HPLC
AUTHORS:
Praveen Rao Balguri, Harish Kumar Cherivirala
KEYWORDS:
HPLC, Buprenorphine Hydrochloride, Naloxone Hydrochloride Dihydrate, Degradation Products, Combined Dosage Form, Stability Indicating Method, Forced Degradation
JOURNAL NAME:
American Journal of Analytical Chemistry,
Vol.16 No.10,
October
24,
2025
ABSTRACT: A stability-indicating reverse-phase high-performance liquid chromatographic (RP-HPLC) method was developed and validated for the simultaneous quantitative determination of degradation products of Buprenorphine and Naloxone in a combination pharmaceutical dosage form. Efficient chromatographic separation was achieved using gradient elution with mixture of acetonitrile and 50 mM potassium phosphate monobasic buffer (adjusted to pH 4.5 with diluted phosphoric acid) as mobile phase A, and acetonitrile as mobile phase B. The separation was performed on a Phenomenex Luna C18 column (4.6 × 100 mm, 3 µm). UV detection was carried out at 280 nm, with flow rates of 1.1 mL/min and 1.2 mL/min. The method was validated in accordance with ICH guidelines to demonstrate specificity, linearity, limits of detection and quantitation, precision, accuracy, robustness, and solution stability. This validated method was successfully applied for the simultaneous quantitative determination of degradation products of Buprenorphine and Naloxone in the combination dosage form during both release testing and shelf-life stability studies.