First-order derivative spectrophotometric estimation of gemifloxacin mesylate and ambroxol HCl in tablet dosage form
DOI:
https://doi.org/10.30574/gscbps.2021.14.2.0034Keywords:
Gemifloxacin mesylate, Ambroxol HCl, First order derivativeAbstract
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.
Metrics
References
Lowe MN, Lamb HM. Gemifloxacin. Drugs. May 2000;59(5): 1137-47.
Ball P, Mandell L, Patou G, Dankner W, Tillotson G. A new respiratory fluoroquinolone, oral gemifloxacin: a safety profile in context. Int J Antimicrob Agents. May 2004;23(5):421-9.
Kantar A, Klimek L, Cazan D, Sperl A, Sent U, Mesquita M. An overview of efficacy and safety of ambroxol for the treatment of acute and chronic respiratory diseases with a special regard to children. MultidiscipRespir Med. 3 Mar 2020; 15(1): 511.
Fischer J, Pschorn U, Vix JM, Peil H, Aicher B, Müller A, de Mey C. Efficacy and tolerability of ambroxol hydrochloride lozenges in sore throat. Randomised, double-blind, placebo-controlled trials regarding the local anaesthetic properties. Arzneimittelforschung. 2002;52(4):256-63.
Indian Pharmacopoeia. Indian Pharmacopoeia Commission, Ghaziabad; Government of India, Ministry of Health and Family Welfare. 2020.
Beckett AH, Stenlake JB. Practical Pharmaceutical Chemistry, part-II; 4th Edn; CBS Publisher and Distributors, New Delhi. 2007.
El-Yazbi FA, Hammud HH, Assi SA. Derivative-ratio spectrophotometric method for the determination of ternary mixture of aspirin, paracetamol and salicylic acid. SpectrochimActa A MolBiomolSpectrosc. 2007; 68(2): 275-8.
Suroshe RS, Wakade RB, Panchale WA, Sakhare AD, Rathod RR, Pophalkar PB. Development and Characterization of Osmotic Drug Delivery System of Model Drug. World Journal of Pharmaceutical Research. 2018; 7(18): 1158-1171.
Kadam CY, Bobade NN, Pophalkar PB, Hole SU, Suroshe RS, Panchale WA. Design and in vitro characterization of phase transition system using rivastigmine tartrate for nasal drug delivery system. World Journal of Pharmaceutical Research. 2018; 8(1): 815-829.
Bakal RL, Manikrao AM, Sahare AY, Manwar JV. Spectrophotometric estimation of amitriptyline HCL and chlordiazepoxide in tablet dosage form, International Journal of Chemical Sciences. 2007; 5(1): 360–364.
Manwar JV, Nagargoje BU, Gurumukhi VC, et al. Application of simultaneous equation method for the determination of azithromycin and cefiximetrihydrate in tablet formulation, Research Journal of Pharmacy and Technology. 2017;10(1): 108-112.
Manwar J, Kumbhar DD, Bakal RL, Baviskar SR, Manmode RS. Response surface based co-optimization of release kinetics and mucoadhesive strength for an oral mucoadhesive tablet of cefiximetri hydrate. Bulletin of Faculty of Pharmacy. Cairo University. 2016; 54: 227–235.
Manwar J, Mahadik K, Paradkar A. Plackett–Burman design: A statistical method for the optimization of fermentation process for the yeast Saccharomyces cerevisiae isolated from the flowers of Woodfordia fruticosa. Fermentation Technology. 2013; 2: 109.
Manwar JV, Mahadik KR, Sathiyanarayanan L, Paradkar AR, Patil SV. Comparative antioxidant potential of Withania somnifera based herbal formulation prepared by traditional and non-traditional fermentation processes. Integr Med Res. 2013; 2: 56-61.
Manwar JV et al. Rapid RP-HPLC method for estimation of zidovudine from tablet dosage form, Der ChemicaSinica. 2011; 2: 152–156.
Panchale WA, Suroshe RS, Rathod MS, Pandhare YL. Chromatographic analysis of famotidine, paracetamol and ibuprofen from tablet formulation. Research Journal of Pharmacy and Technology. 2019; 12: 231-263.
Manwar JV, Mahadik KR, Paradkar AR, Takle SP, Sathiyanarayanan L, Patil SV. Determination of withanolides from the roots and herbal formulation of Withania somnifera by HPLC using DAD and ELSD detector. Der Pharmacia Sinica. 2012; 3: 41–46.
Manmode RS, Dhamankar AK, Manwar JV, Laddha SS. Stability indicating HPLC method for simultaneous determination of methocarbamol and nimesulide from tablet matrix. Der ChemicaSinica.2011; 2: 81–85.
Manwar JV, Patil SS, Bhalerao CA, Mandpe SR, Kumbhar DD. Experimental design approach for chromatographic determination of ketorolac tromethamine from bulk drug and tablet formulation. Global Journal of Pharmacy & Pharmaceutical Sciences. 2017; 3(2): 555-609.
Manwar J, Mahadik K, Paradkar A, Patil S, Sathiyanarayanan L, Manmode R. Gas chromatography method for the determination of non-ethanol volatile compounds in herbal formulation. International Journal of Analytical and Bioanalytical Chemistry. 2013; 3(1): 12-17.
Panchale WA, Badukle NA, Sabhadinde AF, Bakal RL, Manwar JV. Concurrent analysis of ambroxol HCl and salbutamol sulphate from tablet formulation by RP-HPLC. GSC Biological and Pharmaceutical Sciences. 2020; 13(03): 197-202.
Sabhadinde AF, Panchale WA, Manwar JV, Bakal RL. Novel RP-HPLC method for simultaneous analysis of chlorthalidone and telmisartan from combined dosage form. International Journal of Pharmacy and Pharmaceutical Research. 2020; 20(1):491-502.
Manwar JV, Patil SS, Patil B, Jadhao RG, Kumbhar DD, Bakal R. Diclofenac sodium loaded nano sized ethosomes: An Investigation on z-average, polydispersity and stability. J Pharm Res. 2017; 1(3): 000115.
Patil SS, Kumbhar DD, Manwar JV, Jadhao RG, Bakal RL, Wakode S. Ultrasound-assisted facile synthesis of nanostructured hybrid vesicle for the nasal delivery of indomethacin: Response surface optimization, microstructure, and stability. AAPS PharmSciTech. 2019;20(3):97.
Manwar J, Mahadik K, Paradkar A, Sathiyanarayanan L, Vohra M, Patil S. Isolation, biochemical and genetic characterizations of alcohol-producing yeasts from the flowers of Woodfordia fruticosa. J Young Pharm. 2013;5(4):191-194.
Manmode R, Manwar J, Vohra M, Padgilwar S, Bhajipale N. Effect of preparation method on antioxidant activity of ayurvedic formulation kumaryasava. J HomeopAyurv Med. 2012; 1:114.
Nimbokar SW, Badukale NA, Panchale WA, Bakal RL, Gudalwar BR, Manwar JV. Development and validation of RP-HPLC method for determination of zonisamide from tablet formulation. World Journal of Pharmaceutical and Medical Research. 2021;7(2):196-200.
Gouda AA, Amin AS, El-Sheikh R, Yousef AG. Spectrophotometric determination of gemifloxacin mesylate, moxifloxacin hydrochloride, and enrofloxacin in pharmaceutical formulations using acid dyes. J Anal Methods Chem. 2014;2014:286379.
Shamim S, Sultana N, Arayne MS, Akhtar M, Gul S. Optimization and simultaneous determination of gemifloxacin and Non-steroidal anti-inflammatory drugs in bulk, pharmaceutical formulations and human serum by RP-HPLC and its applications. International Research Journal of Pharmacy and Pharmacology. 2012;2(10):245–253.
Suddhasattya Dey et al. Spectrophotometric estimation of gemifloxacin in bulk and pharmaceutical dosage form by Uv spectrophotometr. International Journal of Chemical and Analytical Science. 2010;1(6):130-133.
Begum, MHNK Agarwal, SDuraivel. Analytical method development and validation of gemifloxacin and ambroxol in solid dosage form by RP-HPLC. Ind. J Res. Phar & Bio. 2013; 1:701-706.
Baig MS, Dehghan MHG. Development and validation of in-vitro dissolution studies of gemifloxacin mesylate and ambroxol hydrochloride from its combined sustain release tablet dosage form with respect to accelerated aging conditions by HPLC assay methods. World Journal of Pharmacy and Pharmaceutical Sciences. 2015; 4(8):1965-1981.
Assaleh MH, Assaleh FH. Development of RP-HPLC method for simultaneous estimation of gemifloxacin and ambroxol in tablet formulation. Journal of Pharmacreations.2015; 2(2):33-38.
Raja TA, Atmakuri LR. Development and validation of HPTLC method for the simultaneous estimation of gemifloxacin mesylate and ambroxol hydrochloride in bulk and tablet dosage form. Analytical Chemistry Letters.2012; 2(3):152-158.
Khan H, Zaid Z. Development and validation of a dissolution test with spectrophotometric analysis for gemifloxacin mesylate and ambroxol hydrochloride in tablet dosage form. International Journal of PharmTech Research.2012;4:661.
Wankhede S, Mahajan AM, Chitlange SS. Simultaneous spectrophotometric estimation of gemifloxacin mesylate and ambroxol hydrochloride in tablets. Der PharmaChemica. 2011;3(1):269-273.
Panchale WA, Gulhane CA, Manwar JV, Bakal RL. Simultaneous estimation of salbutamol sulphate and ambroxol HCl from their combined dosage form by UV-Vis spectroscopy using simultaneous equation method. GSC Biological and Pharmaceutical Sciences. 2020; 13(03): 127-134.
Shelke PG, Dewani AP, Vasu SN, Tripathi AS, Bakal RL, Chandewar AV. A validated RP-HPLC method for simultaneous determination of metformin HCl and vildagliptin in pharmaceutical formulation. Int J of Adv in Phar Ana. 2013;3(2):37-41.
ICH, Q2A. International Conference on Harmonization, Geneva. 1994.
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
