UV Spectrophotometric Method Development and Validation of Butorphanol Tartrate in Bulk Drug and Pharmaceutical Formulation
Abstract
The present research work discusses the development and validation of a UV spectrophotometric method for butorphanol tartrate. Simple, accurate and cost efficient spectrophotometric method has been developed for the estimation of butorphanol tartrate in tablet dosage form. The optimum conditions for the analysis of the drug were established. The maximum wavelength (λ max) was found to be 278nm. The percentage recovery of butorphanol tartrate was in the 100.016±0.68. Beers law was obeyed in the concentration range of 2-12μg/ml. Calibration curves shows a linear relationship between the absorbance and concentration. The line equation y = 0.0674x - 0.0057 with r2 of 0.9998was obtained. Validation was performed according to ICH guidelines for linearity, accuracy, precision, LOD and LOQ. The sample solution was stable up to 36 hours. The proposed method may be suitable for the analysis of butorphanol tartrate in tablet formulation for quality control purposes.
Keywords: Butorphanol tartrate, Validation, Precision, Accuracy, LOQ, LOD, ICH guidelines.
Keywords:
Butorphanol tartrate, Validation, Precision, Accuracy, LOQ, LOD, ICH guidelinesDOI
https://doi.org/10.22270/jddt.v14i4.6521References
Joshi GP. Multimodal analgesia techniques and postoperative rehabilita¬tion. Anesthesiol Clin North America, 2005; 23: 185-202. https://doi.org/10.1016/j.atc.2004.11.010 PMid:15763418
Jin F, Chung F. Multimodal analgesia for postoperative pain control. J Clin Anesth, 2001; 13: 524-39. https://doi.org/10.1016/S0952-8180(01)00320-8 PMid:11704453
Buvanendran A, Kroin JS. Useful adjuvants for postoperative pain manage¬ment. Best Pract Res Clin Anaesthesiol, 2007; 21: 31-49. https://doi.org/10.1016/j.bpa.2006.12.003 PMid:17489218
Chen JY, Wu GJ, Mok MS et al. Effect of adding ketorolac to intravenous mor¬phine patient- controlled analgesia on bowel function in colorectal surgery patients-a prospective, randomized double-blind study. Acta Anaesthesiol Scand, 2005; 49: 546-51. https://doi.org/10.1111/j.1399-6576.2005.00674.x PMid:15777304
Wang ZY, Wang CQ, Yang JJ et al. Which has the least immunity depression during postoperative analgesia - morphine, tramadol, or tramadol with lor¬noxicam? Clin Chim Acta, 2006; 369: 40-45. https://doi.org/10.1016/j.cca.2006.01.008 PMid:16487501
Song JW, Shim JK, Song Y et al. Effect of ketamine as an adjunct to intra¬venous patient controlled analgesia, in patients at high risk of postopera¬tive nausea and vomiting undergoing lumbar spinal surgery. Br J Anaesth, 2013; 111: 630-35. https://doi.org/10.1093/bja/aet192 PMid:23744819
Trissel LA, Trusley C, Ben M, Kupiec TC. Physical and chemical stability of palonosetron hydrochloride with five opiate agonists during simulated Y-site administration. Am J Health Syst Pharm, 2007; 64: 1209-13. https://doi.org/10.2146/ajhp060355 PMid:17519464
Sadhasivam S, Boat A, Mahmoud M. Comparison of patient-controlled an¬algesia with and without dexmedetomidine following spine surgery in chil¬dren. J Clin Anesth, 2009; 21: 493-501. https://doi.org/10.1016/j.jclinane.2008.12.017 PMid:20006257
Waldron NH, Jones CA, Gan TJ et al. Habit impact of preoperative dexa¬methasone on postoperative analgesia and side-effects: systematic review and meta-analysis. Br J Anaesth, 2013; 110: 191-200. https://doi.org/10.1093/bja/aes431 PMid:23220857 PMCid:PMC3544008
Wang, F. Z.; Shen, X. F.; Liu, Y. S.; et al. Eur. J. Anaesthesiol. 2009, 26, 28-34. https://doi.org/10.1097/EJA.0b013e32831a6aa2 PMid:19122548
Thakore, B.; D'Mello, J.; Saksena, S.; et al. Acute Pain 2009, 11, 93- 99. https://doi.org/10.1016/j.acpain.2009.09.001
Chen FC, Li P, Zhou BH et al. Stability of an epidural analgesic admixture containing butorphanol tartrate and ropivacaine hydrochloride. Eur J Hosp Pharm, 2015; 22: 7-11. https://doi.org/10.1136/ejhpharm-2014-000450
Chen FC, Fang BX, Li P et al. Compatibility of butorphanol and droperidol in 0.9% sodium chloride injection. Am J Health Syst Pharm, 2013; 70: 515-19. https://doi.org/10.2146/ajhp120324
Fang BX, Zhu J, Chen FC et al. Stability of butorphanol tartrate injection with lornoxicam injection in patient controlled analgesia pump. Cent South Pharm, 2013; 11: 732-34.
Parker WA: Compatibility of perphenazine and butorphanol admixtures. Can J Hosp Pharm, 1980; 33: 152.
Chen F, Fang B, Li P et al: Physico-chemical stability of butorphanol -tram¬adol and butorphanol-fentanyl patient-controlled analgesia infusion solu¬tions over 168 hours. Pharmazie, 2014; 69: 585-88.
International Conference on Harmonisation (2005) Validation of analytical procedures: Text and Methodology, Geneva, Switzerland.
International Conference on Harmonization (ICH), Q2A: Text on Validation of Analytical Procedures: Definitions and Terminology, US FDA Federal Register,. Vol. 60, 1995.
Published



How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).