Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF TOLPERISONE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM

Md. Saiful Islam*, Md. Rafiquzzaman, Md. Taleb Hossain, Sukalyan Kumar Kundu, Taslima Akter, Md. Abul Kalam

ABSTRACT

An accurate, precise and cost effective HPLC method was developed for estimation of Tolperisone hydrochloride. Separation of the drug was achieved on a reverse phase C18 column using a mobile phase consisting of phosphate buffer and acetonitrile in the ratio of 72: 28 (v/v). The flow rate was 1mL/min and detection wavelength was 257 nm. The linearity was observed in the range of 25 to 75μgmL-1 with a correlation coefficient (R2) of 0.999. The retention time of Tolperisone hydrochloride was 5.45±0.03 min. The LOD and LOQ values were found to be 2.29 and 6.95 μgmL-1 respectively. The proposed method was validated as per the ICH guidelines for the parameters: linearity, accuracy, precision, robustness etc. This method can be employed for routine quality control analysis of Tolperisone hydrochloride in bulk, and tablet dosage form.

Keywords: Tolperisone hydrochloride tablets, Potency, RP-HPLC, Method validation.