A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF KETOROLAC TROMETHAMINE AND TRAMADOL HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMS.


Bharathi Devi Y, Sumanth Srinivas Kamatham, Bhaskara Raju V, Mohan Gandhi B, Srinivas K

Abstract


Objective: This study was embarked upon to develop a new, simple, rapid, validated reversed-phase high-performance liquid chromatography (HPLC)
method for the estimation of ketorolac tromethamine (KET) and tramadol hydrochloride (TDL) in pharmaceutical dosage forms.

Methods: The HPLC method was developed on Shishiedo C18 column (250 mm × 4.6 mm i.d, 5 μ) using methanol: 50 mM phosphate buffer (pH 6.0) in the ratio of 52:48 at 282 nm.

Results: Retention time for the drugs was found to be 5.1 and 6.9 minutes for tramadol and ketorolac, respectively. The limit of detection for tramadol
and ketorolac were found to be 1.0 and 0.1 μg/ml, limit of quantitation for tramadol and ketorolac were found to be 5.0 and 0.5 μg/ml, respectively. Linearity was established in the range of 20.0-30.0 μg/ml and 8.0-12.0 μg/ml for TDL and KET, respectively. The method was precise with % relative standard deviation <2 for both intra- and interday precision. The accuracy of the method was performed over three levels of concentration, and the recovery was in the range of 98-102%.

Conclusion: From the found experimental data, it can be concluded that the developed method is accurate, precise, and selective and can be employed
successfully for the estimation of KET and TDL in Pharmaceutical dosage forms.

 


Keywords


Reversed-phase high-performance liquid chromatography, Ketorolac tromethamine, Tramadol hydrochloride.

| PDF |

References


López-Muñoz FJ, Díaz-Reval MI, Terrón JA, Déciga-Campos M. Analysis of the analgesic interactions between ketorolac and tramadol during arthritic nociception in rat. Eur J Pharmacol 2004;484(2-3):157-65.

Lehmann KA. Tramadol in acute pain. Drugs 1997;53 Suppl 2:25-33.

Klotz U. Tramadol - the impact of its pharmacokinetic and pharmacodynamic properties on the clinical management of pain. Arzneimittelforschung 2003;53(10):681-7.

Abanmy NO, Zaghloul IY, Radwan MA. Compatibility of tramadolhydrochloride injection with selected drugs and solutions. Am J Health Syst Pharm 2005;62(12):1299-302.

Barcia E, Martín A, Azuara ML, Sánchez Y, Negro S. Tramadol and hyoscine N-butyl bromide combined in infusion solutions: Compatibility and stability. Support Care Cancer 2007;15(1):57-62.

Scott LJ, Perry CM. Tramadol: A review of its use in perioperative pain. Drugs 2000;60(1):139-76.

Lin TF, Lin FS, Chou WH, Yeh YC, Lin CP, Fan SZ, et al. Compatibility and stability of binary mixtures of ketorolac tromethamine and tramadol hydrochloride injection concentrate and diluted infusion solution. Acta Anaesthesiol Taiwan 2010;48(3):117-21.

Cabrera J, Mancuso M, Cabrera-Fránquiz F, Limiñana J, Díez A. Stability and compatibility of the mixture of tramadol, ketorolac, metoclopramide and ranitidine in a solution for intravenous perfusion.Farm Hosp 2011;35:80-3.

Manikandan K, Kathiravan K, Rajan PV, Kumar KS, Karuppasamy C,Radhakrishnan K. Development and validation of tramadol HCl in bulkand solid dosage form. Int J Biol Pharm Res 2010;3(2);245-51.

Riddhi P, Falguni T, Nikita P. Ratio spectra derivative UVspectrophotometric method for simultaneous estimation of ketorolactromethamine and phenylephrine hydrochloride in immediate releasetablet. Int J Pharm Pharm Sci 2015;7(11):13-6.

Lydia J, Snehalatha B. UV spectrophotometric method for simultaneousestimation of Tramadol hydrochloride and Aceclofenac in bulk andtablet dosage form. Int J Pharm Pharm Sci 2016;8(5):334-40.

Fig. 6: Graph of linearity of ketorolac tromethamine and tramadol hydrochloride AQ1Table 9: Assay data of marketed formulationDrug Amount labeled (mg) Amount found % AssayKET 10 9.65 mg 99.36TDL 25 24.74 mg 99.71 KET: Ketorolac tromethamine, TDL: Tramadol hydrochloride

Tsvetkova BG, Pencheva PI, Peikov TP. HPLC Determination ofketorolac tromethamine in tablet dosage forms. Der Pharma Sinica2012;3(4):400-3.

Kamble RM, Singh GS, Singh S. Validated RP-HPLC methodfor simultaneous estimation of paracetamol and tramadol HCl incommercial tablet. J Pharm Res 2011;4(11):4038-40.

Chawla P, Pathak A, Singh R. Method development and validation for simultaneous estimation of ketorolac and sparfloxacin by RP-HPLC. Int J Pharm Biol Res 2013;1(4):95-101.

Kundu S, Majumdar T, Ray SK, Barat PK. Development and validation of a HPLC-UV method for simultaneous determination of moxifloxacin and ketorolac tromethamine in ocular formulation. Int J Pharm Sci Res

;5(7):2902-7.

Kumaraswamy G, Kumar JM, Bhikshapati DV, Venkatesh G, Spandana R. A validated method for simultaneous estimation of febuxostat and ketorolac tromethamine in pharmaceutical formulations. J Drug Deliv Ther 2012;2(3):173-6.

Babu BH, Narayana PV, Krishna VR. Development and validation of liquid chromatographic method for the simultaneous estimation of ofloxacin hydrochloride and ketorolac tromethamine in combined dosage form. Am J Pharm Tech Res 2014;4(2):281-91.

Patel D, Patel M, Patel K. Simultaneous RP-HPLC estimation of moxifloxacin hydrochloride and ketorolac tromethamine in ophthalmic dosage forms. Asian J Res Chem 2012;5(5):698-700.

Singh RA, Chandra P, Sathiyanarayanan L, Ramoo MK. Application of HPLC for the simultaneous determination of aceclofenac, paracetamol and tramadol hydrochloride in pharmaceutical dosage forms. Sci Pharm

;80(2):337.

Patelia E, Bahir K, Mehta FA. Simultaneous estimation of tramadol HCl, paracetamol and domperidone in pharmaceutical formulations by RP-HPLC method. J Chromat Sep Tech 2012;3:8.

Bhadane RN, Kachave RN, Jain D. Simultaneous estimation of tramadol HCl, paracetamol and domperidone by RP-HPLC in tablet formulation. J Liq Chromatogr Relat Technol 2010;33(6):786-92.

Patel J, Patel P. RP-HPLC method development and validation for the estimation of diclofenac sodium, tramadol hydrochloride and chlorzoxazone from their combined tablet dosage form. Int J Pharm Pharm Sci 2014;6(7):632-7.

Prathap B, Dey A, Rao GH. Analytical method development and validation for simultaneous estimation of febuxostat and ketorolac in bulk and pharmaceutical dosage form in rat plasma by RP-HPLC. Indo Am J Pharm Res 2014;4(4):1717-29.

Tambe VS, Deodhar MN, Prakya V. LC and LC-MS study for simultaneous determination of tramadol hydrochloride and ketorolac tromethamine in bulk and formulation with their major degradation products. Bull Fac Pharm Cairo Univ 2016;54(1):87-97.

Manish S, Vivek V. RP-HPLC method development and validation of tramadol hydrochloride in bulk form by ion-pair liquid chromatography. J Drug Del Ther 2014;4(1):63-5.




About this article

Title

A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF KETOROLAC TROMETHAMINE AND TRAMADOL HYDROCHLORIDE IN PHARMACEUTICAL DOSAGE FORMS.

Keywords

Reversed-phase high-performance liquid chromatography, Ketorolac tromethamine, Tramadol hydrochloride.

DOI

10.22159/ajpcr.2017.v10i5.15976

Date

01-05-2017

Additional Links

Manuscript Submission

Journal

Asian Journal of Pharmaceutical and Clinical Research
Vol 10 Issue 5 May 2017 Page: 186-190

Print ISSN

0974-2441

Online ISSN

2455-3891

Authors & Affiliations

Bharathi Devi Y
India

Sumanth Srinivas Kamatham
sri vasavi institute of pharmaceutical sciences
India

Bhaskara Raju V
sri vasavi institute of pharmaceutical sciences
India

Mohan Gandhi B
sri vasavi institute of pharmaceutical sciences
India

Srinivas K
sri vasavi institute of pharmaceutical sciences
India


Article Tools


Email this article (Login required)
Email the author (Login required)

Refbacks

  • There are currently no refbacks.