Open Access Subscription Access
Open Access Subscription Access
Validated Simultaneous UV Spectrophotometric Methods for Estimation of Tramadol Hydrochloride and Ketorolac Tromethamine in Bulk and Marketed Capsule Formulation
The present study describes new, simple, rapid and novel spectrophotometric methods for simultaneous estimation of Tramadol Hydrochloride and Ketorolac Tromethamine in bulk and capsule formulation. The combination was analysed by simultaneous equation method (Method A), Absorbance correction method (Method B) and First order derivative spectroscopic method (Method C). Method A involved measurement of absorbance at two wavelengths, 271 nm and 246 nm, λmax of Tramadol hydrochloride and Ketorolac tromethamine respectively. For method B, wavelengths 331 nm (for determination of Ketorolac tromethamine) and 271 nm were used. For method C, wavelengths 339.2 nm (Zero crossing of Tramadol hydrochloride) and 229.4 nm (Zero crossing of Ketorolac tromethamine) were used for determination of Ketorolac tromethamine and Tramadol hydrochloride respectively. Beer’s law was obeyed in concentration range of 5-50 μg/ ml and 2-20 μg/ ml for Tramadol hydrochloride and Ketorolac tromethamine respectively by all the methods. Method C was found to be more simple and sensitive. The proposed methods are recommended for routine analysis of pharmaceutical formulations due to their specificity, rapidity, simplicity and accuracy. These methods were validated for linearity, accuracy and precision as per ICH guidelines.
Tramadol Hydrochloride, Ketorolac Tromethamine, UV Spectroscopy.
- Tripathi KD. Essentials of Medical Pharmacology. Jaypee Publishers, 6th ed. 460-61.
- Goodman and Gilmans, The Pharmacological Basis of Therapeutics, 11th ed. 697-698.
- Küçük A and Kadioğlu Y. Determination of tramadol hydrochloride in ampoule dosage forms by using UV spectrophotometric and HPLC-DAD methods in methanol and water media. Farmaco. 2005; Feb 60(2):163-9.
- Gharge D and Dhabale P. Simultaneous Estimation of Tramadol Hydrochloride and Paracetamol by UV Spectrophotometric Method from Tablet Formulation. International Journal of Pharm Tech Research. 2(2); 2010: 1119-1123.
- Jain V and Sharma R. Simultaneous Spectrophotometric Estimation and Validation of Domperidone, Tramadol hydrochloride and acetaminophen in tablet dosage form. Stamford Journal of Pharmaceutical Sciences. 3(1); 2010: 28-33.
- Gogulamudi L and Sujana K. Development and validation of UV spectroscopic method for determination of Tramadol hydrochloride in bulk and formulation. International Journal of Pharmacy and Pharmaceutical Sciences. 4(5); 2012: 275-279.
- Tarek B, Tamer A and Randall C. Determination of Paracetamol and Tramadol Hydrochloride in Pharmaceutical Mixture Using HPLC and GC-MS. Journal of Chromatographic Sciences. 47 (10); 2009: 849-854.
- Saccomanni G, Del Carloa S, Giorgi M, Manera C and Sabac A. Determination of tramadol and metabolites by HPLC-FL and HPLC–MS/MS in urine of dogs. Journal of pharmaceutical and biomedical analysis. 53; 2010: 194-199.
- Mehran J, Mohammad M and Behrouz A. On-line clean-up and determination of tramadol in human plasma and urine samples using molecularly imprinted monolithic column coupling with HPLC. Journal of Chromatography B. 911; 2012: 49– 54.
- Vojko K and Robert R. HPLC determination of tramadol in human breast milk. Journal of pharmaceutical and biomedical analysis. 32; 2003: 1061-1066.
- Prakash MS and Meena S. Fluorophotometric Determination of Ketororlac Tromethamine. Indian Drugs. 33;1996: 149-151.
- Devarajan PV, Gore SP and Chavan SV. HPTLC Determination of Ketorolac Tromethamine. Journal of pharmaceutical and biomedical analysis. 22; 2000: 679-683.
- Irene T, Frances C, Martin K, Marian P and Anne W. HPLC Method for the Determination of Ketorolac in Human Plasma. Journal of liquid Chromatography and Related Technology. 1996;19(6):957-967.
- Chaudhary RS, Gangwal SS, Jindal KC and Khanna S. Reversed-phase high-performance liquid chromatography of ketorolac and its application to bioequivalence studies in human serum. Journal of Chromatogr B: Biomedical Sciences and Applications. 614(1);1993:180-184.
- Yang G, He B and Liu S. Determination of the content of ketorolac tromethamine in injection by HPLC. Chinese Journal of Hospital Pharmacy. 12;2003: 12-15.
- Reddy BP, Suryanarayana MV, Vemkatraman S, Krupadanam GL and Sastry CS. Purity Evaluation of Ketorolac Tromethamine by HPLC. Indian Drugs. 30;1993:176-179.
- Patri S, Patni AK, Iyer SS, Khuroo AH, Tausif M and Rana SA. Validated High-Performance Liquid Chromatography-Tandem Mass Spectrometric (LC-MS/MS) Method for Simultaneous Determination of R(+)-Ketorolac and S(−)-Ketorolac in Human Plasma and its Application to a Bioequivalence Study. Chromatography Research International. 11;2011:1-11.
- Tambe VS, Deodhar MN and 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. Bulletin of Faculty of Pharmacy, Cairo University. 54; 2016: 87–97..
Abstract Views: 549
PDF Views: 1