Development and Validation of First Order Derivative Method for Estimation of Betahistine Dihydrochloride and Prochlorperazine Maleate in Tablet Dosage Form

Author(s)

Patel, V. D., Patel, P. U.

Author's Affiliation

Abstract

A simple, precise, and accurate method was developed for the estimation of Betahistine Dihydrochloride (BET) and Prochlorperazine Maleate (PRO) in Tablet dosage form using first order derivative spectrophotometry. Wavelengths selected for quantitation were 252.9 nm for Betahistine Dihydrochloride (zero crossing point for PRO) and 260.15 nm for Prochlorperazine maleate (zero crossing point for BET). The method was validated with respect to linearity, accuracy, precision, limit of detection and limit of quantitation in accordance with the International Conference on Harmonisation (ICH) guidelines. Linearity was observed in a concentration range of 4-24μg/ml and 3-18μg/ml for Betahistine Dihydrochloride and Prochlorperazine maleate, respectively. The limit of detection and limit of quantitation were found to be 0.29μg/ml and 0.95μg/ml for Betahistine Dihydrochloride and 0.34μg/ml and 1.12μg/ml for Prochlorperazine maleate. The percentage recovery of Betahistine Dihydrochloride and Prochlorperazine maleate was found to be 99.38% and 99.11% respectively. The % R.S.D. values for intra-day and inter-day precision study were <2.0%, confirming that the method was sufficiently precise. The method can be successfully employed for the simultaneous estimation of Betahistine Dihydrochloride and Prochlorperazine maleate in tablet dosage form.

Keywords

Betahistine Dihydrochloride, Prochlorperazine Maleate, Derivative spectrophotometry, First order, Validation

Cite This Article

Patel, V. D., & Patel, P. U. (2014). Development and Validation of First Order Derivative Method for Estimation of Betahistine Dihydrochloride and Prochlorperazine Maleate in Tablet Dosage Form. International Journal for Pharmaceutical Research Scholars, 3(1), 51-56.