HPLC Method of Rabeprazole sodium (20 mg) and Itopride (150 mg) Capsule

Description:   Visual                                                                                                                                        (Complies/ Not Complies)

Identification: The HPLC-chromatogram of the sample complies with standard chromatogram.        (Complies/ Not Complies)

Assay: Rabeprazole sodium (20 mg) and Itopride (150 mg)

Cinematographic condition:-

    Column : C18 ( 250 x 4.6 cm)

    Wavelength : 280 nm

    Injection volume : 20 µl

    Flow rate : 1 ml/ min

    Mobile phase Preparation:  600ml buffer + 400ml Acetonitrile

[Preparation of Buffer:1.46gm KH2PO4 + 525mg K2HPO4  à adjust pH 7.4 with OPA]

Procedure:-

W.S.  : 23 mg Rabeprazole sodium + 150 mg Itopride in  100 ml  volumetric flask add 20 ml HPLC grade methanol. sonicate for 20 min.

2 ml of above solution in 25 ml volumetric flask make up to mark with mobile phase.

Sample : Weight equivalent to Avg.fill  in 100 ml Volumetric flask dissolve with 20 ml HPLC grade methanol,sonicate for 20 min.                               make up to mark with methanol

2 ml of above solution in 25 ml volumetric flask make up to mark with mobile phase.

Calculation :-   

Rabeprazole sodium (20 mg):  (90.0% to 110.0%)

Working standard weight =

Sample weight                  =

Working standard area     =

Sample area                      =

Calculation:-

Test area                   ws wt              2                    100               25                p

= ———————–X———–X————-X————X————X———-X average fill

            ws area                    100                25            test wt              2                 100

Itopride (150 mg) : (90.0% to 110.0%)

Working standard weight =

Sample weight                  =

Working standard area     =

Sample area                      =

Calculation:-

Test area              ws wt                 2                100                25                 P

=  ———————-X———–X————-X————X————X———-X Average fill

                         ws area             100                25                Test wt             2               100

 

 

HPLC Method