RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF GATIFLOXACIN AND AMBROXOL HCL IN PHARMACEUTICAL DOSAGE FORM
Keywords:
RP-HPLC, Method development, Gatifloxacin, Ambroxol HCl, ValidationAbstract
Objective: To develop a simple, selective, linear, precise and accurate RP-HPLC method for simultaneous estimation of Gatifloxacin and Ambroxol HCl in tablet dosage form.
Methods: The chromatographic separation was performed using Inerstil ODS-3V (4.6 x 250 mm, 5 µm particle size). Mobile phase was composed of phosphate Buffer pH-5 and methanol (40:60v/v) at a flow rate of 1 ml/min. Detection was carried out using PDA detector at 237 nm. The method was validated as per ICH guidelines.
Results: The retention times for Gatifloxacin and Ambroxol HCl were observed as 2.443 and 4.863 min respectively. Linearity range was observed in concentration of 32-112 µg/ml for Gatifloxacin and 6-21 µg/ml for Ambroxol HCl. The percentage recoveries of Gatifloxacin and Ambroxol HCl are 99.64% and 99.78% respectively. The correlation coefficients for both the components are close to 1.
Conclusion: This method is simple, selective, linear, precise, accurate and sensitive hence can be successfully employed for the routine quality control of dosage forms containing both the drugs in pharmaceutical industries.
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References
http: //www. wikipedia. org/Gatifloxacin.
Perry CM, Ormrod D, Hurst M, Onrust SV. Gatifloxacin: a review of its use in the management of bacterial infections. Drugs 2002;62(1):169-207.
Lawrence MT, Stephen JM, Maxine AP. Current medical diagnosis and treatment. 42nd ed. India: The McGraw Hill Companies Inc; 2003.
http: //www. wikipedia. org/Ambroxol HCl.
Rele RV, Gurav PJ. Simple Spectrophotometric methods for determination of ambroxol hydrochloride from pharmaceutical formulation. Int J Pharm Tech Res 2012;4(3):994-8.
Gillissen A, Nowak D. Characterisation of N-acetylcysteine and ambroxol in anti-oxidant therapy. Respir Med 1988;92(4):609-23.
Kuchekar BS, Shinde GS, Naikawadi IT, Todkar KJ, Kharade SV. Spectrophotometric estimation of ambroxol hydrochloride in tablets. Indian J Pharm Sci 2003;65(2):193-5.
Swapna M, Sarkar DG, Reddy NM, Rao KKV. Spectrophotometric determination of ambroxol. Indian J Pharm Sci 1998;60(4):249-51.
Suma BV, Kannan K, Madhavan V, Chandini RN. Spectrophotometric estimation of ambroxol hydrochloride in bulk and tablet formulation. World J Pharm Pharm Sci 2014;3(2):2090-7.
Sivasubramanian L, Muthukumaran A. Spectrophotometric determination of gatifloxacin in pharmaceutical formulations and biological samples. Indian J Pharm Sci 2006;68(5):672-5.
Maheshwari RK, Upadhya N, Jain J, Patani M, Pandey R. New spectrophotometric analysis of gatifloxacin tablets utilizing mixed solvency concept (at 288 nm). Der Phar Lett 2012;4(1):1-4.
Prabu SL, Thiagarajan S, Srinivasan M, Marina Q. Simultaneous estimation of gatifloxacin and ambroxol HCL by uv spectrophotometry. Int J Pharm Sci Rev Res 2010;3(2):123-6.
Prathap B, Nagarajan G, Dinakar A, Rao GS, Rathor RSB, Shahul H. Spectrophotometric method for simultaneous estimation of gatifloxacin and ambroxol hydrochloride in tablet dosage form. Der Pharm Lett 2011;3(3):62-8.
Dincer Z, Basan H, Goger NG. Quantitative determination of ambroxol in tablects by derivative UV spectroscopy method and HPLC. J Pharm Biomed Anal 2003;31:867-72.
Boopathy D, Mathew B, Prakash M, Sureshkumar S, Perumal P. Simultaneous estimation and method validation of gatifloxacin and ambroxol hydrochloride in tablet dosage form by RP-HPLC. Der Pharm Lett 2010;2(2):346-9.
Prathap B, Rajendran SS, Dinakar A, Rao GS, Ashok Kumar J, Roosewelt C. Simultaneous determination of gatifloxacin and ambroxol hydrochloride from tablet dosage form using RP-HPLC. Int J Res Pharm Sci 2010;1(3):325-7.
ICH Q2B Validation of Analytical Procedures: Methodology. International conference on Harmonisation, IFPMA, Geneva; 1996.
USP 29/NF 24. The United States Pharmacopoeia National Formulary, (24thedn), Rockville, MD: United States Pharmacopoeial Convention Inc; 2006. p. 1964-6.