1Department of Chemistry, Bapatla Engineering College, Bapatla - 522102, Andhra Pradesh, India
2Departments of Chemistry, VRS & YRN College of Engineering and Technology, Chirala - 523155, Andhra Pradesh, India
3Department of Chemistry, Ch.S.D. St. Theresa’s College for Women, Eluru-534003, Andhra Pradesh, India
This study describes the development and validation of reverse phase HPLC method for the estimation of L- Methyl Folate and Tofisopam in combined formulation. The separation was accomplished on a LUNA C18, 250*4.6mm ID, 5pm column connected to a PDA detector using 0.1% ortho phosphoric acid in water as mobile phase A and acetonitrile as mobile phase B, under gradient elution. Mobile phase flow rate was maintained at 1.0 ml/min. The detection of the constituents was done at 234nm using a UV detector. The performance of the method was validated according to the current ICH requirements. LOD and LOQ for all impurities and L-Methyl Folate and Tofisopam were established with respect to the test concentration. Specificity, accuracy, precision, ruggedness and robustness were determined as part of the method validation. All statistical results were within the acceptance criteria and the proposed method is simple, fast, accurate, precise and reproducible hence, it can be applicable for routine analysis for testing chromatographic purity of L-Methyl Folate and Tofisopam.
RP-HPLC, Validation, L-Methyl Folate and Tofisopam
