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Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS DETERMINATION OF AMOXICILLIN AND RANITIDINE IN PHARMACEUTICAL FORMULATIONS

Shaheen Perveen*, Shahnaz Gauhar, Rabia Ismail Yousuf, Muhammad Harris Shoaib, Anab Fatima Sheikh

ABSTRACT

The objective of the study was to develop and validate a simple and sensitive RP-HPLC method for simultaneous determination of amoxicillin and ranitidine in pharmaceutical formulations. The chromatographic system consisted of a LC-10 AT VP pump, SPD-10 AVP UV/visible detector. The separation was achieved from Hibar- Purospher star RP-18e (5 μm, 250 x 4.6 mm) column at ambient temperature with a mobile phase consisting of 0.02M phosphate buffer: Acetonitrile (93:7 v/v, pH 3.0) at a flow rate of 1.0 ml/ minute and the retention times were about 8 and 11 minutes for amoxicillin and ranitidine respectively. The peak separation was detected at 230nm. The calibration curve was linear over the concentration range of 0.15μg/mL to 20μg/mL for amoxicillin and 0.039μg/ml to 20μg/ml for ranitidine. The proposed method is accurate, precise, and reproducible within the desired range. The limit of detection was found to be 0.039μg/mL and 0.0195μg/mL and limit of quantification was found to be 0.078μg/mL and 0.039μg/mL for amoxicillin and ranitidine respectively. Therefore this method could be used as a more convenient and efficient option for the analysis of amoxicillin and ranitidine in pharmaceutical dosage form as well as this method can also give help in the pharmacokinetic study of the same drug.

Keywords: Amoxicillin, Ranitidine, simultaneous determination, RP-HPLC method.


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