Hplc Method Development and Its Validation for Simultaneous Estimation of Tolperisone Hydrochoride and Diclofenac Sodium in Combined Tablet Dosage Form

Authors: Jain Dipesh, Jain Pallavi

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Abstract

Introduction

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results1 .The objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose. A tabular summation of the characteristics applicable to identification, control of impurities and assay procedures is included. Other analytical procedures may be considered in future additions to this document2 .

Conclusion

The novel RP- HPLC methods has been developed for the simultaneous estimation of Tolperisone hydrochloride and Diclofenac sodium in combined tablet dosage is simple, precise, specific, accurate, quick reliable and reproducible. The method gave good resolution for both the drugs with a short analysis time below 6 minutes. The method was completely validated showing satisfactory data for all the method validation parameters tested. The results indicate that the described method can be used for analysis of the compound. The amount found in formulation well agreed with label claim in present of excipients. Thus, the reported method is considerable importance and has great industrial applicability for quality control and analysis of tolperisone hydrochloride and diclofeanc sodium in combined tablet dosage from. This method can also be used for the routine analysis of this combination in other pharmaceutical formulation.