Simultaneous Determination and Validation of Flupirtine Maleate and Paracetamol in Combined Dosage Form by Chromatographic Technique
Dillip Kumar Dash *
Department of Pharmacy, Sumandeep Vidyapeeth Deemed to be University, At/Po. Piparia, Vadodara, Gujarat - 391760, India and N. R. Vekaria Institute of Pharmacy, C L College Campus, Bilkha Road, Junagadh, Gujarat – 3620, India.
Ashim Kumar Sen
Department of Pharmacy, Sumandeep Vidyapeeth Deemed to be University, At/Po. Piparia, Vadodara, Gujarat - 391760, India.
S. Saisivam
N. R. Vekaria Institute of Pharmacy, C L College Campus, Bilkha Road, Junagadh, Gujarat – 3620, India.
Piyushkumar Sadhu
Department of Pharmacy, Sumandeep Vidyapeeth Deemed to be University, At/Po. Piparia, Vadodara, Gujarat - 391760, India.
Shivkant Patel
Department of Pharmacy, Sumandeep Vidyapeeth Deemed to be University, At/Po. Piparia, Vadodara, Gujarat - 391760, India.
Sunil Baile
Department of Pharmacy, Sumandeep Vidyapeeth Deemed to be University, At/Po. Piparia, Vadodara, Gujarat - 391760, India.
*Author to whom correspondence should be addressed.
Abstract
Objective: The focus of this research was to establish a validated high-performance thin layer chromatographic (HPTLC) method for analysing Flupirtine maleate and Paracetamol in a combined dosage form.
Method: Paracetamol and Flupirtine maleate were measured using a mobile phase of Ethyl acetate: Chloroform (7:5 v/v) at 286 nm. This technique was validated in accordance with the International Conference on Harmonization (ICH) guidelines.
Results: The Rf value for paracetamol was 0.31 and 0.52 for Flupirtine maleate in this existing technique. Paracetamol's linearity was found to be in the range of 3250-6500 ng/band, while Flupirtine maleate's linearity was found to be in the range of 1000-2000 ng/band. The method's accuracy was determined by recovery experiments, which revealed a percent recovery of 98 to 102 percent. The % RSD was determined to be less than 2 in the Precision investigation, and the assay result for both compounds was within the limit.
Keywords: Flupirtine maleate, paracetamol, HPTLC, lupirtin-P