Abstract
Different HPTLC-densitometric and RP-HPLC methods are developed for the simultaneous determination of salbutamol sulphate, bromhexine hydrochloride and etofylline in pharmaceutical tablets. HPTLC method was based on separation of all three drugs followed by densitometric measurements of their spots at 275 nm using CAMAG, TLC scanner III. The separation was carried out on Merck HPTLC aluminium plates of silica gel 60 F254, using acetone: methanol: formic acid (9:3:0.01) as mobile phase at room temperature (25 ± 2°C). The HPLC separation was carried out using a mobile phase consisting of 0.02 M ammonium acetate buffer: organic phase (where organic phase MeOH: ACN in ratio of 70:30) adjusted to pH 4.5 with gradient elution. The column used was Waters Spherisorb®C18 bonded with 5 μm (4.6 x 250 mm) with a flow rate of 1 mL min-1 and UV detection at 275 nm simultaneously. The mean recovery ofboth HPTLC and HPLC methods were found to be within 99.44 to 99.85 % w/w. Both HPTLCdensitometric and RP-HPLC methods were statistically validated and can be used for analysis of combined dose tablet formulation containing salbutamol sulphate, bromhexine hydrochloride and etofylline.
Highlights
Salbutamol sulphate (SS), as shown in Figure 1 chemically known as bis [(1RS)-2-[(1, 1-dimethylethyl) amino]-1-[4-hydroxy3-(hydroxymethyl) phenyl] ethanol] sulphate, is beta adenocepter agonist
No RP-HPLC and HPLC methods could be traced for the analysis of SS, Bromhexine hydrochloride (BH) and ET in their combined dosage forms
HPTLC method: Chromatographic separations are significantly affected by mobile phase conditions, such as type and composition of organic modifiers before selecting proper chromatographic conditions, numbers of preliminary trials were conducted with different combinations of different organic solvents, compositions, to obtain satisfactory retention factor, resolution, and other chromatographic parameters
Summary
Salbutamol sulphate (SS), as shown in Figure 1 chemically known as bis [(1RS)-2-[(1, 1-dimethylethyl) amino]-1-[4-hydroxy3-(hydroxymethyl) phenyl] ethanol] sulphate, is beta adenocepter agonist. The standard solutions were prepared by dilution of the stock standard solutions with MeOH (for HPTLC method) or with the mobile phase composition (for HPLC method) to obtain 10 μg mL-1 These solutions were used for optimization of proposed methods to reach the calibration curve for specified each method.Commercial formulations containing tablets of Eto-Salbetol (Batch Number-BTK0017, Kare Labs Pvt. Ltd., Goa , India), which were labeled to contain 2 mg of SS, 8 mg of BH and 200 mg of ET per tablets were used for the study. HPTLC method: Chromatographic separations are significantly affected by mobile phase conditions, such as type and composition of organic modifiers before selecting proper chromatographic conditions, numbers of preliminary trials were conducted with different combinations of different organic solvents, compositions, to obtain satisfactory retention factor, resolution, and other chromatographic parameters. Purity of band of SS, BH and ET in sample (Figure 5) was determined by HPLC chromatogram by comparing UV absorption spectra at the start, middle, and end position of band with that of reference
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