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Dushyant Patel Summary and Conclusion

S.K.P.C.P.E.R., Kherva 80 M .Pharm. Thesis

BTB showed λ

max

at 416 nm and 421 nm, respectively. These developed methods were

used for the estimation

of GBP from two formulations. Both methods involve formation of ion-associated

complex with BCG and BTB at pH 4.0 exhibiting λ

max

at 416 nm and 421 nm,

respectively.

¾ The proposed methods were based on addition of an amine in its ionized form to an

ionized dye, yield a salt (ion-pair) that was extracted into an organic solvent such as

chloroform or dichloromethane. The indicator dye was added and the pH of the aqueous

solution was adjusted to a value where both the amine and dye were in the ionized forms.

The ion pair was extracted by extraction into the organic solvent. In these methods

Beer’s law was obeyed with BCG and BTB in the concentration range of 10-120 µg/ml

and 40-90 µg/ml, respectively.

¾ The optimum conditions for color development had been established by varying the

different parameters involved. For testing the accuracy and reproducibility of the

proposed methods, recovery studies were performed. The data obtained by recovery

studies indicate non-interference from the excipients used in the formulations. The

percentage recoveries were close to 100%. This study revealed that the common

excipients and other additives such as lactose, starch, gelatin, talc and magnesium

stearate that are usually present in the tablet dosage forms do not interfere in the analysis.

Thus, it can be concluded that the proposed methods are found to be simple, precise and

accurate that can be used for the determination of GBP in their pharmaceutical dosage

forms in a routine manner.

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