Asian Journal of Research in Chemistry

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Development and Validation of RP-HPLC Method for Simultaneous Estimation of Gatifloxacin and Loteprednol Etabonate in Pharmaceutical Dosage Form


Affiliations
1 Department of Quality Assurance, S.K. Patel College of Pharmaceutical Education & Research, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India
     

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A simple, accurate, and rapid reversed phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Gatifloxacin (GTF) and Loteprednol etabonate (LTP) in ophthalmic suspension. The separation was carried out using mobile phase consisting of methanol: phosphate buffer (pH, 6.0): Acetonitrile (65:25:10 v/v/v) with flow rate 1.0 ml/min using PDA detection at 264 nm. The column used was Phenomenex C18, (150 mm x 4.6 mm i.d., 5 μm). The method was linear over a concentration range 2 - 35 μg/ml for both drugs. The retention time of Gatifloxacin and Loteprednol etabonate were found to be 2.31 min and 5.36 min, respectively. Results of analysis were validated statistically. The mean recovery was 100.73 ± 1.11 and 99.74 ± 0.69 for GTF and LTP, respectively. The limit of detection (LOD) and the limit of quantification (LOQ) for GTF and LTP were found to be 0.103 and 0.312 μg/ml and 0.118 and 0.360 μg/ml, respectively. The results of the study showed that the proposed RP-HPLC method was found to be simple, sensitive, precise and accurate and also useful for the routine analysis of GTF and LTP in pharmaceutical dosage form

Keywords

Gatifloxacin, Loteprednol Etabonate, RP-HPLC, Validation
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  • Maryadele. J. O’ Neil. The Merck Index: An Encyclopedia of chemicals, drugs and biologicals, 14th edition. New Jersey: Published by Merck Research Laboratories, Division of Merck and Co., Inc. Whitehouse station, 2006, p.4376.

  • Indian Pharmacopoeia. Vol. III. The Controller of Publication. 6th ed. Govt. of India. New Delhi. 2010, p.1402-1404.

  • K Ilango, P Valentina, K.S. Lakshmi, A. Canhea, S.R. Abraham, V.B. Raju, A.K. Kumar, UV Spectroscopic And Colorimetric Methods For The Estimation Of Gatifloxacin In Tablet Dosage Forms. Indian Journal of Pharmaceutical Sciences, 68(2), 2006, 273-275.

  • S. Lakshmi, A. Muthukumaran, Spectrophotometric Determination Of Gatifloxacin In Pharmaceutical Formulations And Biological Sample, Indian Journal of Pharmaceutical Sciences, 2006, 68(5), 672-675.

  • S. Paramane et al., Simultaneous Spectrophotometric Estimation of Gatifloxacin and Ornidazole In Tablet Dosage Form, Indian Journal of Pharmaceutical Sciences, 2006, 68(6), 819-821.

  • P. U Patel et al., Simultaneous Spectrophotometric Estimation of Gatifloxacin and Ornidazole In Mixture, Indian Journal of Pharmaceutical Sciences, 2005, 67(3), 356-357.

  • S. Lakshmi, A. Muthukumaran , RP-HPLC Estimation Of Gatifloxacin In Tablets, Indian Journal of Pharmaceutical Sciences, 2005, 67(3), 367-369.

  • T.R. Shirke, N. Pai, Reverse Phase High Performance Liquid Chromatographic Determination of Gatifloxacin in gatifloxacin Eye Drops, Asian Journal of Chemistry, 2004, 16 (1), 546-548.

  • K. R. Sireesha and K. Prakash, Simultaneous Determination Of Gatifloxacin And Dexamethasone Sodium Phosphate In Bulk And Pharmaceutical Formulations by HPLC African Journal of Pharmacy and Pharmacology, 2011, 5(17), 1990-1995.

  • S.N. Razzaq et al., Development And Validation Of Gatifloxacine And Ketorolac Tromethamine In Combined Dosage Form By Liquid Chromatographic Method, Journal of Liquid Chromatography and Related Technologies, 2012, 35(5), 651-661.

  • A. B. Patel , N. J. Shah, N. M. Patel, Development and Validation of HPLC Method for the Simultaneous Estimation of Satranidazole and Gatifloxacin in Tablet Dosage Form. International Journal of ChemTech Research, 2009, 1(3), 587- 590.

  • S.A. Shah et al., A Simple And Sensitive HPTLC Method For Estimation Of Gatifloxacin In Tablet Dosage. Indian Journal of Pharmaceutical Sciences, 2004, 66 (3), 306-308.

  • G. Sowmiya et al., HPTLC Method For The Determination Of Gatifloxacin In Human Plasma, Indian Journal of Pharmaceutical Sciences, 2007, 69(2), 301-302.

  • J. Jane, E.V.S. Subrahmanyam, D. Sathyanarayana, Spectrophotometric Determination of Gatifloxacin, Asian Journal of Chemistry, 2006, 18 (4), 3210-3212.

  • K. Venugopal, S. Movva, R.N. Saha, New, Rapid, And Sensitive Spectrofluorimetric Method For The Estimation Of Gatifloxacin In Bulk And Formulation, Indian Journal of Pharmaceutical Sciences, 2006, 68(6), 726-730.

  • Maryadele. J. O’ Neil. The Merck Index: An Encyclopedia of chemicals, drugs and biologicals, 14th edition. New Jersey: Published by Merck Research Laboratories, Division of Merck and Co., Inc. Whitehouse station, 2006, p.967.

  • V.L. McDevitt , J. Huang , M.J. Brubaker, Stability Indicating Gradient HPLC Method For The Determination Of Loteprednol Etabonate And Related Substances In A Finished Ophthalmic Product, Bausch & Lomb Pharmaceuticals, Tampa, FL.

  • S. Yasueda et al., An HPLC Method To Evaluate Purity Of A Steroidal Drug, Loteprednol Etabonate, Journal of Pharmaceutical and Biomedical Analysis, 2004, 36, 309–316.

  • G. Lunn , HPLC Methods for recently approved Pharmaceuticals, A John Wiley & Sons INC. Publications, Hoboken, New Jersey, 2005, 362-363.

  • The International Conference on Harmonization, Q2 (R1), Validation of Analytical Procedure, Text and Methodology, 2005.


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  • Development and Validation of RP-HPLC Method for Simultaneous Estimation of Gatifloxacin and Loteprednol Etabonate in Pharmaceutical Dosage Form

Abstract Views: 756  |  PDF Views: 2

Authors

Ankit B. Patel
Department of Quality Assurance, S.K. Patel College of Pharmaceutical Education & Research, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India
Dipti B. Patel
Department of Quality Assurance, S.K. Patel College of Pharmaceutical Education & Research, Ganpat University, Ganpat Vidyanagar – 384012, Mehsana, Gujarat, India

Abstract


A simple, accurate, and rapid reversed phase high performance liquid chromatographic method has been developed and validated for the simultaneous estimation of Gatifloxacin (GTF) and Loteprednol etabonate (LTP) in ophthalmic suspension. The separation was carried out using mobile phase consisting of methanol: phosphate buffer (pH, 6.0): Acetonitrile (65:25:10 v/v/v) with flow rate 1.0 ml/min using PDA detection at 264 nm. The column used was Phenomenex C18, (150 mm x 4.6 mm i.d., 5 μm). The method was linear over a concentration range 2 - 35 μg/ml for both drugs. The retention time of Gatifloxacin and Loteprednol etabonate were found to be 2.31 min and 5.36 min, respectively. Results of analysis were validated statistically. The mean recovery was 100.73 ± 1.11 and 99.74 ± 0.69 for GTF and LTP, respectively. The limit of detection (LOD) and the limit of quantification (LOQ) for GTF and LTP were found to be 0.103 and 0.312 μg/ml and 0.118 and 0.360 μg/ml, respectively. The results of the study showed that the proposed RP-HPLC method was found to be simple, sensitive, precise and accurate and also useful for the routine analysis of GTF and LTP in pharmaceutical dosage form

Keywords


Gatifloxacin, Loteprednol Etabonate, RP-HPLC, Validation

References