Concurrent analysis of ambroxol HCl and salbutamol sulphate from tablet formulation by RP-HPLC
DOI:
https://doi.org/10.30574/gscbps.2020.13.3.0404Keywords:
RP-HPLC, Ambroxol HCl, Salbutamol sulphate, ValidationAbstract
RP-HPLC method was developed for concurrent analysis of ambroxol HCl and salbutamol sulphate from tablet formulation. Analytes were separated with mobile phase consisting of mixture of methanol and water (0.1% triethylamine) in the ratio 50: 50 at a flow rate of 0.7 ml/min with Nucleosil (4.6 mm I.D x 250 mm) C18 column. The retention time of ambroxol HCl and salbutamol sulphate was found to be 3.61 and 6.20 min, respectively. The detection was carried out at 224 nm. The dynamic range for ambroxol HCl and salbutamol sulphate observed was 15-75 µg/ml and 1-5 µg/ml, respectively. The percent recovery obtained for ambroxol HCl and salbutamol sulphate were close to 100%. Obtained statistical data of results was found to satisfactorily.
Metrics
References
Morgan DJ, Paull JD, Richmond BH, Wilson-Evered E, Ziccone SP. Pharmacokinetics of intravenous and oral salbutamol and its sulphate conjugate. Br J Clin Pharmacol. 1986;22(5):587-93.
Indian Pharmacopoeia. Indian Pharmacopoeia Commission, Ghaziabad; Government of India, Ministry of Health and Family Welfare. 2014;2: 1025
Ruffin RE, Latimer KM, Crockett AJ, Blight MM. A comparative bronchodilator study of salbutamol and salbutamol sulphate that were administered by metered-dose inhalers. The Medical Journal of Australia. 1989;150(5): 274-277.
British Pharmacopoeia. British Pharmacopeia Commission, Ministry of health and social services, UK. 1988; 1:497.
Hindle M, Chrystyn H. Determination of the relative bioavailability of salbutamol to the lung following inhalation. Br J Clin Pharmacol. 1992;34(4):311-5.
Pophalkar PB, Wakade RB, Hole SU, Kadam CY, Suroshe RS. Panchale WA. Development and Evaluation of Ondansetron Medicated Jelly. World Journal of Pharmaceutical Research. 2018; 7(19): 1252-1263.
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 Biological and 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 cefixime trihydrate 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 cefixime trihydrate. 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 Chemica Sinica 2011; 2(5): 152-156
Panchale WA, Suroshe RS, Rathod MS, and 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, and Laddha SS. Stability indicating HPLC method for simultaneous determination of methocarbamol and nimesulide from tablet matrix. Der Chemica Sinica.2011; 2: 81–85.
Manwar JV, Mandpe SR, Patil SS, Bhalerao CA, Mandpe SR, Kumbhar DD, Jadhao RG, Bakal RL. 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.
Sadasivam, RubeshA new RP-HPLC method development and validation for the simultanious estimation of salbutamol sulphate and theophyline in Pharmaceutical dosage form. International Journal of Universal Pharmacy and Bio Sciences. 2013; 2: 218-226.
Yogesh S, et al., Method development and validation of salbutamol sulphate and its related impurities by RP-HPLC. International Journal of Pharmaceutical Sciences. 2011; 3:15-4.
Pai PN, Rao GK, Murthy MS, Agarwal A, Puranik S. Simultaneous determination of salbutamol sulphate and bromhexine hydrochloride in tablets by reverse phase liquid chromatography. Indian J Pharm Sci. 2009;71(1):53-5.
Bhatia NM, Ganbavale SK, Bhatia MS, More HN, Kokil SU. RP-HPLC and Spectrophotometric Estimation of Ambroxol Hydrochloride and Cetirizine Hydrochloride in Combined Dosage Form. Indian J Pharm Sci. 2008;70(5):603-608.
Itagimatha N, Manjunatha DH. RP-HPLC-UV method development and validation for simultaneous determination of terbutaline sulphate, ambroxol HCl and guaifenesin in pure and dosage forms. Annales Pharmaceutiques Françaises. 2019; 77(4):295-301
Muralidharan S, Kumar JR, Dhanara SA. Development and validation of an high-performance liquid chromatographic, and a ultraviolet spectrophotometric method for determination of Ambroxol hydrochloride in pharmaceutical preparations. J Adv Pharm Technol Res. 2013;4(1):65-8.
Sharma D, Kumar D, Singh M, Singh M, Rathore MS. Spectrophotometric method development and validation for simultaneous estimation of Salbutamol Sulphate and Ambroxol Hydrochloride in combined dosage forms.. International Journal of Drug Development & Research. 2013; 5: 124-132.
Patel PA, Dole MN, Shedpure PS, Sawant S. Spectrophotometric simultaneous estimation of salbutamol and ambroxol in bulk and formulation. 2011; 4(3).
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.
ICH, Q2A (1994) International Conference on Harmonization, Geneva
Manwar JV, Vispute SS, Kumbhar DD, Manmode RS, Bakal RL, Jadhao RG, Jogdand SD. Response surface based optimization of system variables for liquid chromatographic analysis of candesartan cilexetil. Journal of Taibah University for Science. 2017; 11: 159–172.
Ravi Sankar S. Text book of Pharmaceutical Analysis. Rx Publications, Tiruneveli, India. 4th Edn. 13-17.
Downloads
Published
How to Cite
Issue
Section
License
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.