Volume : 09, Issue : 10, October – 2022

Title:

66.STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF NALOXONE IN BULK AND PHARMACEUTICAL FORM BY USING RP-HPLC
‬

Authors :

Thatiparthi Divya, Vijaya Kuchanna

Abstract :

In the current work, an endeavour be situated made to give a fresher, delicate, basic, precise and minimal effort RP-HPLC technique. It is effectively applied for the assurance of Naloxone in drug arrangements without the obstructions of other component in the details. In HPLC strategy, HPLC conditions were upgraded to get, a sufficient detachment of eluted mixes. At first, different portable stage pieces were attempted, to come to be great ideal outcomes. Portable stage and stream rate choice be subject to on top boundaries (tallness, resulting, imaginary plates, limit factor), run time and so on the milieu with Buffer: acetonitrile (43:57) with 1 ml/min river rate is very strong.The ideal frequency for identification was 254 nm at which better indicator reaction for drug was gotten. The normal conservation time for Naloxone were discovered to be 2.2. Framework appositeness tests are an essential piece of chromatographic strategy. They are applied to check the duplicability of the chromatographic framework. To discover its adequacy, framework reasonableness tests were done on newly arranged stock activities. The alignment was direct in focus scope of 60 – 100 mg/ml. The low estimations of % R.S.D. show the strategy is exact and precise. The mean recuperations be situated found in the scope of 99.8%– 101.4%. Sample worth and quality of the sample were assessed using three illustrations of five and three different concentrations, respectively, prepared and analysed on the same day. Variability on a day-to-day basis was measured using three concentrations analysed over three separate days over a three-day period. The precision also reproducibility of the assay are seen in these data.
Keywords: Naloxone, RP‐HPLC, Method development, Validation

Cite This Article:

References:

1. Weinstein SH, Pfeffer M, Schor JM, Indindoli L, Mintz M: Metabolites of naloxone in human urine. J Pharm Sci. 1971 Oct;60(10):1567-8. doi: 10.1002/jps.2600601030. [Article]
2. Rzasa Lynn R, Galinkin JL: Naloxone dosage for opioid reversal: current evidence and clinical implications. Ther Adv Drug Saf. 2018 Jan;9(1):63-88. doi: 10.1177/2042098617744161. Epub 2017 Dec 13. [Article]
3. Papathanasiou T, Springborg AD, Kongstad KT, Staerk D, Moller K, Taylor BK, Lund TM, Werner MU: High-dose naloxone, an experimental tool uncovering latent sensitisation: pharmacokinetics in humans. Br J Anaesth. 2019 Aug;123(2):e204-e214. doi: 10.1016/j.bja.2018.12.007. Epub 2019 Jan 18. [Article]
4. Gil-Alegre ME, Barone ML, Torres-Suárez AI. Extraction and determination by liquid chromatography and spectrophotometry of naloxone in microparticles for drug-addiction treatment. J Sep Sci 2005;28:2086-93.
5. Mostafa ST, Mohamed EM, Mahmoud MA. Determination of naloxone hydrochloride in dosage form by high-performance liquid chromatography. J Liquid Chromatogr 1983;6:1491-97.
6. Panchagnula R, Sharma P, Khandavilli S, Varma MV. RP-HPLC method and its validation for the determination of naloxone from a novel transdermal formulation. Farmaco 2004;59:839-42.
7. Reid RW, Deakin A, Leehey DJ. Measurement of naloxone in plasma using high-performance liquid chromatography with electrochemical detection. J Chromatogr 1993;614:117-22.
8. Franklin M, Odontiadis J. Determination of naloxone in human plasma by high-performance liquid chromatography with coulometric detection. J Chromatogr B Biomed Appl 1996;679:199-203.
9. Fang WB, Chang Y, McCance-Katz EF, Moody DE. Determination of naloxone and nornaloxone (noroxymorphone) by high-performance liquid chromatography-electrospray ionization- tandem mass spectrometry. J Anal Toxicol 2009;33:409-17.