Method development and validation of stability indicating RP-HPLC method for simultaneous estimation of tolperisone HCL and etodolac in bulk and its pharmaceutical formulations

Author(s): Ganta Srinivas*, Suryadevara Vidyadhara, Ganji Ramanaiah, Srilakshmi V.

Abstract

A rapid and sensitive Reverse Phase High Performance Liquid Chromatographic [RP-HPLC] method was developed for the estimation of Tolperisone and Etodolac1,2,3 in pure and its tablet dosage forms. The method was validated as per International Conference on Harmonization [ICH] guidelines35. A C18 column (250×4.6mm, 5μm) was used with a mobile phase containing a mixture of potassium phosphate monohydrate buffer (pH-2.6) and Acetonitrile in the ratio of 70:30% v/v. The analysis was performed with run time of 6 minutes at a flow rate of 1ml/min. The Tolperisone and Etodolac was monitored at 263nm with UV detection and Tolperisone and Etodolac was eluted at 2.8 min and 4.2 min. The method was linear (r2 =0.999) at concentration ranging from 7.5 to 25μg/ml for Tolperisone and 100-300µg/ml for Etodolac, precise (intra-day relative standard deviation [RSD] and inter-day RSD values < 1.0%), accurate (99.3 to 100.9 for Tolperisone and 100.1 to 100.6 for etodolac), specific and robust. Detection limit of 1.30 for Tolperisone and 1.88 μg/ml for Etodolac. Similarly quantification limits were 3.93 for Tolperisone and 5.70 for Etodolac μg/ml, estimated from linearity by regression respectively. The results showed that the proposed method is suitable for the precise, accurate and rapid determination of Tolperisone and Etodolac in bulk, its combined dosage forms.

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