Abstract

Aim of present work was to develop and validate a simple, precise and accurate uv-vis spectrophotometric method for the simultaneous estimation of gemifloxacin mesylate (GEMI) and ambroxol HCl (AMB) in their combined tablet dosage form. The method is based on first-order derivative spectroscopy. For determination of sampling wavelengths, each of GEMI and AMB were scanned in the wavelength range of 200–400 nm in the spectrum mode and sampling wavelengths were selected at 360 nm (zero crossing of GEMI) where AMB showed considerable absorbance and at 221.6 nm (zero crossing of AMB) where GEMI showed considerable absorbance. The linearity was obtained in the concentration range of 32-192 µg/ml for GEMI and 7.5-45 µg/ml for AMB. The correlation coefficients were found to be 0.9987 and 0.9992 for GEMI and AMB, respectively. The method was validated as per ICH guidelines. Mean recoveries were found satisfactory. All the data of validation study was found to be satisfactorily. The proposed method can be applied for simultaneous estimation of both the drugs

Highlights

  • Gemifloxacin mesylate (GEMI), chemicaly is (R, S)-7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-1, 8-naphthyridine-3-carboxylic acid (Fig. 1)

  • Gemifloxacin acts by inhibiting bacterial DNA synthesis by binding to bacterial topoisomerases II (DNA gyrase) and IV, resulting in bacterial death

  • Pure gift sample of GEMI and Ambroxol HCl (AMB) were obtained from Glenmark pharmaceuticals Ltd., Hosur and Dr Reddy's laboratories, Hyderabad, respectively

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Summary

Introduction

Gemifloxacin mesylate (GEMI), chemicaly is (R, S)-7-[(4Z)-3-(aminomethyl)-4-(methoxyimino)-1-pyrrolidinyl]-1cyclopropyl-6-fluoro-1, 4-dihydro-4-oxo-1, 8-naphthyridine-3-carboxylic acid (Fig. 1). After observing the overlain first-order derivative spectra with scaling factor = 4 and Δλ = 4 for GEMI and AMB (Fig. 2-B), zero crossing points of drugs were selected for the analysis of other drugs. The first wavelength selected was 360 nm (zero crossing of GEMI), where AMB showed considerable absorbance. The second wavelength selected was 221.6 nm (zero crossing of AMB), where GEMI showed considerable absorbance.

Results
Conclusion
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