Development and Validation of a Simple HPLC-UV Method for Determination of Amoxicillin trihydrate in Bulk Drug and Pharmaceutical Dosage Forms.

BACKGROUND

Many analytical methods for testing amoxicillin trihydrate from different monographs such as United States and British pharmacopoeia, use acetonitrile HPLC grade as an organic solvent in the mobile phase; however, this solvent is expensive and not environmentally friendly.

OBJECTIVES

Developing and validating a simple, affordable, accurate, precise and environmentally friendly HPLC-UV method, for determining amoxicillin in formulations by using methanol HPLC grade as an organic solvent in the mobile phase.

METHODS

An HPLC system was used for developing and validation of laboratory test method which is less expensive and uses environmentally-friendly mixture of mobile phase solutions. Specificity, linearity, precision, repeatability, and accuracy were studied.

RESULTS

The retention time (RT) for amoxicillin was 3.53 ± 0.020 min, and no interfering peaks were recorded with the blank, standard and sample at RT, ensuring specificity. Calibration curve of 20 to 160µg/ml was used. The correlation coefficient (r)=0.9998, which indicates that the method has the linearity to this range of 20 to 160µg/ml. Intra- and between days' repeatability were assessed by injecting solutions three times a day and within three days. The %RSD of 0.3% and 0.7% within and between days respectively, were recorded. The %RSD was ≤ 2%, which indicates a precision of the method. An average percent recovery of 100.5±3.6% was recorded.

CONCLUSION

An environmentally-friendly, simple, affordable, selective, specific, rapid, sensitive, repeatable, with precision and accurate HPLC-UV method, has been developed and validated for the estimation of amoxicillin trihydrate in pharmaceutical dosage forms and can be adopted for the purpose of quality control.