Abstract
Objective: The objective of the study was to develope a stability indicating high-performance liquid chromatographic (HPLC) method for simultaneous assay of pentazocine and naloxone in bulk and tablets.
 Methods: Pentazocine and naloxone were analyzed on Dionex C18 column using 0.1M K2HPO4 buffer (pH 4.0) and methanol (60:40, v/v) as the mobile phase. The concentration of pentazocine and naloxone was quantified by photodiode array detector set at 248 nm. The method was validated in compliance with ICH rules. Pentazocine and naloxone tablet formulation was subjected to forced degradation such as acid, neutral and alkali hydrolysis, oxidation, photo, and thermal degradation.
 Results: The method was linear, with R2=0.9999 in the concentration range 100–300 μg/ml for pentazocine and R2=0.9995 in the concentration range 1–3 μg/ml for naloxone. The level of detection and quantification was 0.097 μg/ml and 0.322 μg/ml for pentazocine and 0.0073 μg/ml and 0.0243 μg/ml for naloxone, respectively. The degraded products are resolved well from pentazocine and naloxone with significantly different retention time values. From validation results, it was proved that the method is selective, precise, robust, and accurate for the estimation of pentazocine and naloxone simultaneously.
 Conclusion: The developed stability-indicating HPLC method can be applied for quantitative determination of pentazocine and naloxone in tablets.
Highlights
Pentazocine, chemically known as (2RS,6RS,11RS)-6, 11-dimethyl-3(3-methylbut-2-en-1-yl)-1,2,3,4,5,6-hexahydro-2,6-methano-3benzazocin-8-ol (Fig. 1), is an synthetic opioid
Pentazocine is used as a pain reliever for moderate to severe pain [3,4,5]
Materials Pentazocine (98% purity) and naloxone (98% purity) were procured from Rainbow Pharma Training Lab (Hyderabad, India)
Summary
Pentazocine, chemically known as (2RS,6RS,11RS)-6, 11-dimethyl-3(3-methylbut-2-en-1-yl)-1,2,3,4,5,6-hexahydro-2,6-methano-3benzazocin-8-ol (Fig. 1), is an synthetic opioid. It has agonist activity at ƙ and σ opiate receptors and antagonist activity at μ opiate receptor [1,2,3]. Pentazocine is used as a pain reliever for moderate to severe pain [3,4,5]. Chemically known as (4R,4aS,7aR,12bS)-4a,9-dihydroxy3-prop-2-enyl-2,4,5,6,7a,13-hexahydro-1H-4,12-methanobenzofuro [3,2-e]isoquinoline-7-one (Fig. 1), is a synthetic N-allyl oxymorphone derivative with opiate antagonist activity [6,7]. It has antagonist activity at ƙ, μ, and σ opiate receptors. Naloxone is used in emergency cases to reverse respiratory depression due to overdoses of opioids such as morphine, heroin, and other opioids [8,9,10,11]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
