Stability Indicating Liquid Chromatographic Method Development for Estimation of Buprenorphine Hydrochloride and Naloxone Hydrochloride in Tablet Formulation: Development and Validation Consideration

2018 Asian journal of biochemical and pharmaceutical research  
This article describes simple isocratic reverse-phase high-performance liquid chromatographic method (RP-HPLC) developed for the simultaneous quantification of buprenorphine hydrochloride (BUP) and naloxone hydrochloride (NLX) in active pharmaceutical ingredient and pharmaceuticals. The separation of the two drugs was achieved using a C₁₈ column (250mm×4.0mm, 5µ) as a stationary phase. The mobile phase was used as a mixture of acetonitrile; methanol; and 10 mM potassium phosphate buffer (pH 3.5
more » ... adjusted by orthophosphoric acid) with an isocratic ratio of 70:10:20 v/v. Detection was performed by using PDA detector at 210 nm. Buprenorphine hydrochloride (RT= 5.504 minutes) and naloxone hydrochloride (RT= 3.353 minutes) were separated in a single chromatographic run with resolution of 8.719. The calibration plot showed good linear relationship with r 2 = 0.998 for buprenorphine hydrochloride and r 2 = 0.999 for naloxone hydrochloride in concentration range of 6 -14 µg/ml. The recoveries for Buprenorphine hydrochloride and naloxone hydrochloride were found to be 99.00% and 99.75%, respectively. The developed analytical method was validated and found satisfactory as per ICH guidelines for linearity, precision, accuracy, specificity, limit of detection, limit of quantification, robustness and stability. Buprenorphine hydrochloride and naloxone hydrochloride individually as well as in combination were subjected to different stress conditions like acid, base, oxidation, thermal and photolytic degradation and peaks of a degraded product were well resolved from peaks of pure drug. This method is simple, rapid and suitable for routine quality control analysis.
doi:10.24214/ajbpr/8/2/0819 fatcat:nvrhmhyfyfb5dforhs7hn3pmau