Assay Method for Simultaneous Determination of Terbutaline Sulphate, Bromhexine Hydrochloride and Guaifenesin

Terbutaline Sulphate, Bromhexine Hydrochloride and Guaifenesin Syrup contains:

Each 5mL contains:

Terbutaline Sulphate ..... 1.25mg

Bromhexine Hydrochloride ..... 2.0mg

Guaifenesin ..... 50mg

Chromatographic Conditions:

Column: 150 mm × 4.6 mm, 5 µm. C18 

Flow Rate: 1.0 mL/minute 

Column Temperature: 30°C 

Detection Wavelength: 248 nm (Bromhexine Hydrochloride), 280 nm (Terbutaline Sulphate and Guaifenesin)

Injection Volume: 10 µL 

Mobile Phase: Phosphate Buffer : Acetonitrile  (80 : 20, v/v) 

Preparation of Phosphate Buffer:

The phosphate buffer is prepared by dissolving 8.95 g of disodium hydrogen phosphate dodecahydrate and 3.40 g of potassium dihydrogen orthophosphate in 1000 ml water and final pH was adjusted by adding orthophosphoric acid and 2N sodium hydroxide. Filtered through 0.45 μm nylon filter and degassed before use.

Preparation of Diluent:

Mixing of phosphate buffer (pH to 3.5) with acetonitrile in the ratio of 80:20.

Preparation of Standard Solution:

Weigh accurately 13mg of terbutaline sulphate, 20mg of bromhexine hydrochloride and 500mg of guaifenesin working standard and transfer into 500 mL volumetric flask add 300 mL Diluent, sonicate for 15 minutes, make up the volume with Diluent & mix. 

Transfer 10 mL of Solution in 25 mL volumetric add 10 mL Diluent, sonicate for 5 minutes, make up the volume with Diluent & mix. Filter through 0.45µ filter.

Preparation of Sample  Solution: 

Shake the bottle before sampling. Transfer 5g of syrup solution to a 50mL volumetric flask. Add diluent to bring the volume to 40 mL, sonicate for 20 min, then dilute to volume with the diluent. Transfer 10 mL of Solution in 25mL volumetric add 10 mL Diluent, sonicate for 5 minutes, make up the volume with Diluent & mix. Filter through 0.45µ filter.

Calculation: 

Calculate the percentage of labeled amount:

                                        Where, 

                                              At - Average Area of Sample 

                                              As - Average Area of Standard 

                                              Ws - Weight of Standard 

                                              Wt - Weight of Sample (g) 

                                              SG - Specific Gravity

                                              L – Label Claim

                                              P – Potency of Standard

PEOPLE ALSO READ: Ultra-Violet Assay Method for Erythromycin Tablets