Abstract
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.
Highlights
Ambroxol HCl (trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride), an mucolytic agent official in Indian Pharmacopoeia [1,2]
Standard drugs were obtained as gift samples from Grandix Pharma Ltd., Mumbai and tablet formulations (Sal MucoliteTM, contents- AMB- 30 mg &SLS - 2 mg) were purchased from local medical shop
Evaluation of system suitability parameters The system suitability test was performed by collecting data from five replicate injections (20 μl) of mixed standard solution at selected chromatographic conditions
Summary
Ambroxol HCl (trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol hydrochloride), an mucolytic agent official in Indian Pharmacopoeia [1,2]. Salbutamol sulphate ((RS-1-(4-hydroxy-3-hydroxymethylphenyl)-2-(tertbutylamino)ethanol sulphate) is beta adrenoceptor agonist, official in British Pharmacopoeia [3,4]. It used in management of asthma [5]. There are number of analytical methods for the analysis of pharmaceutical drugs from different formulations [6,7,8,9,10,11,12,13,14,15,16,17,18,19]. In literature there are two of UVspectroscopic methods and one HPLC available for simultaneous analysis of ambroxol HCl and salbutamol sulphate in combined dosage form [26,27,28]. Attempts were made to develop new RP-HPLC method for the concurrent analysis of ambroxol HCl (AMB) and salbutamol sulphate (SLS) from tablet the formulation
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