RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DICLOFENAC SODIUM, TRAMADOL HYDROCHLORIDE AND CHLORZOXAZONE FROM THEIR COMBINED TABLET DOSAGE FORM
Keywords:Diclofenac sodium, Tramadol Hydrochloride, Chlorzoxazone, RP-HPLC method, Analytical method validation
Objective: The objective of the current study was to develop and validate the RP-HPLC method for the simultaneous estimation of Tramadol Hydrochloride, Chlorzoxazone and Diclofenac sodium from their combined tablet dosage form
Methods: The current method describes RP-HPLC method for the estimation of Tramadol Hydrochloride, Chlorzoxazone and Diclofenac sodium from their combined tablet dosage form. The mobile phase used was Acetonitrile: 0.05M Disodium Hydrogen Phosphate buffer pH 3.5 adjusted with 10% v/v Ortho Phosphoric acid(50:50 v/v) and Hypersil ODS C18 (250 mm x4.6 mm, 5.0 Î¼ particle sizes) was used as a stationary phase with detection wavelength of 220 nm.
Result: Linearity was obtained in the concentration range of 15-75 Î¼g/ml, 100-500 Î¼g/ml and 20-100 Î¼g/ml for TRM,CHL and DIC respectively. The % recovery was found to be 99.41 -99.84%, 99.30 - 99.74 % and 99.6 - 99.97 % for DIC, TRM andCHL respectively. The LOQ was found to be 3.33, 3.95 and 36.71 Î¼g/ml for DIC, TRM andCHL respectively. The proposed method has been validated as perICH Q2R1 guidelines and successfully applied to the estimation of TRM, DIC andCHL from their combined Tablet dosage form.
Conclusion: The method was found to be simple, accurate, precise, and suitable for the estimation of Tramadol Hydrochloride, Chlorzoxazone and Dicofenac sodium from their combined tablet dosage form.
Indian pharmacopoeia. Delhi: Govt. of India. Ministry of health & family welfare, the controller & publication. Vol. III; 2010.p. 2245-7.
British Pharmacopoeia. London: The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA); 2003. p. 1868-9.
United States Pharmacopoeia and National Formulary. 36th Asian Edition USA: The United States Pharmacopoeia Convention Inc. p. 5435-6.
Indian pharmacopoeia.Delhi: Govt. of India, Ministry of health & family welfare, the controller & publication. Vol. II; 2010.p. 1199-1201.
British Pharmacopoeia. London: The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), Volume I; 2003. p. 605-6.
United States Pharmacopoeia and National Formulary. 36th Asian Edition USA: The United States Pharmacopoeia Convention Inc. p. 3220-1, 2972-4.
Prajapati JM, Prajapati HR. Development and validation of derivative spectrophotometric method for the quantitative estimation of tramadol hydrochloride and aceclofenac in tablet dosage forms. J of Pharmacy Res 2011; 4(9): 2950-3.
Puranik M, Hirudkar A, Wadher SJ, Yeole PG. Development and validation of spectrophotometric methods for simultaneous estimation of Tramadol Hydrochloride and Chlorzoxazone in Tablet Dosage form. Indian J of Pharm Sci 2006; 68(6): 737-9.
El-sayed AY, Mohamed KM, Hilal MA, Mohamed SA, Aboul-hagag KE, Nasser AY. Development And Validation Of High-performance Liquid Chromatographyâ€“diode Array Detector Method For The Determination Of Tramadol In Human Saliva. J Chromatograph Separat Techniq 2011; 2(4): 1-6.
Ahir KB, Patelia EM, Mehta FA. Simultaneous Estimation of Tramadol HCl, Paracetamol and Domperidone in Pharmaceutical Formulation by RP-HPLC Method. J Chromatograph Separat Techniq 2012; 3(8): 1-5.
Chandra P, Rathore A, Lohidasan S, Mahadik KR. Application of HPLC for the Simultaneous Determination of Aceclofenac, Paracetamol and Tramadol Hydrochloride in Pharmaceutical Dosage. J Form Sci Pharm 2012; 80: 337-51.
Desai P, Captain A,Kamdar S. Development and Validation of HPTLC Method for Estimation of Tramadol HCl in Bulk and in Capsule Dosage Form. Int J of Pharm Tech Res 2012; 4(3): 1261-5.
Kanakapura BV, Hosakere DR, Xavier CM, Pavagada JR, Madihalli SR. A Stability Indicating UPLC Method for the Determination of Tramadol Hydrochloride: Application to Pharmaceutical Analysis. J Chromatogr Res Int 2012; 1-9.
Patel A, Patel J, Shah A. Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Tramadol Hydrochloride and Diclofenac Sodium in Tablet Dosage Form. Int J of Pharmacy and Pharm Sci 2012; 4(5): 496-500.
Atto RA. New Method for Determination of Diclofenac Sodium by High Performance Liquid Chromatography. Tikrit J of Pharm Sci 2012; 8(1):60-7.
Dhaneshwar SR, Bhusari VK. Validated HPLC Method for Simultaneous Quantitation of Diclofenac Sodium and Misoprostol in Bulk Drug and Formulation. J Der Chemica Sinica 2010; 1(2): 110-8.
Choudhary B, Goyal A, Khokra S L, Kaushik D. Simultaneous Estimation of Diclofenac Sodium and Rabiprazole by Hplc Method in Combined Dosage Form. Int J of Pharm Sci and Drug Res 2009; 1(1): 43-5.
Kulkarni MB, Dange PB, Walode SG. Stability indicating thin-layer chromatographic determination of Chlorzoxazone, Diclofenac sodium and Paracetamol as bulk drug: application to forced degradation study. J Der Pharmacia Sinica 2012; 3(6): 643-52.
Praksah TB, Vijayasri K, Rama Krishna S. Determination of diclofenac potassium in human plasma by LC-MS. Asian J Chem 2009; 21(6): 4183-9.
Patel SA, Prajapati KM. Spectrophotometric Method for simultaneous estimation of chlorzoxazone and diclofenac sodium in synthetic mixture. Int Res J of Pharmacy 2012; 3(9): 293-6.
Sinde VM, Desai BS, Tendolkar NM. Simultaneous determination of paracetamol, diclofenac Na and chlorzoxazone by HPLC from tablet. Indian J Pharm Sci 1995; 57(1): 35-7.
Abdelaleem EA, Abdelwahab NS. Stability-indicating TLC â€“ densitometric Method for Simultaneous Determination of Paracetamol and Chlorzoxazone and their Toxic Impurities. J of Chromatographic Sci 2012; 1â€“5.
ICH Harmonized Tripartite Guidelines. Validation of analytical procedures: Text and Methodology Q2 (R1) Geneva; 2005.