A Novel Stability Indicating Method for Determination of Major Alkaloid in Black Pepper by RP-HPLC in Different Pharmaceutical Dosage Forms

Background: Piperine is the major alkaloid found in the fruits of Black pepper. Recent studies revealed the antiurolithiatic effect of piperine. So, an attempt was made to develop an analytical method for the assay of Piperine in the formulated dosage forms. Objectives: The present study was done with the aim of developing a simple, accurate, precise and sensitive RP-HPLC method for estimation of Piperine in different dosage forms. Materials and Methods: Some trials were performed during method development using different solvents, mobile phase compositions and flow rate for the estimation of piperine in the dosage form. The developed optimized method was validated as per ICH guidelines and was employed to estimate the amount of piperine in the given dosage form. Results: The optimized chromatographic conditions were achieved using BDS C8 column with mobile phase having of water: Acetonitrile in 50: 50 ratio at 1.0ml/min flow rate. Detection was observed at 247nm using PDA detector. The retention time obtained for piperine peak was found to be 2.4 min. Conclusion: The analytical method which was developed for estimation of piperine is simple, rapid, economic, specific, precise, stable and can be successfully employed for its estimation in syrup and tablet dosage forms.

Keywords: Piperine, Tablet and syrup dosage forms, RP-HPLC, Validation, ICH guidelines,