DEVELOPMENT OF SHORT & ROBUST ANALYTICAL METHOD ON UPLC-MS FOR QUANTITATIVE ESTIMATION OF DIFFERENT API’S IN THEIR FORMULATED PRODUCTS – A GREEN ANALYTICAL CHEMISTRY APPROACH
Tapeesh Bharti* and Richa Singhal
ABSTRACT
As over 70% of pharmaceutical compounds are bases, the analysis of these basic compounds by liquid chromatography (LC) continues to be of great value and interest. The novel approach towards Green Analytical Chemistry was carried out to develop and validate a rapid and selective analytical method by using Reverse Phase Ultra Performance Liquid Chromatography (RP-UPLC) technique for quantitative estimation of different API’s in raw materials & their pharmaceutical dosage forms. The development was done by using a known solution which contain an equimolar ratio of Propanolol, Veraprmil, Niflumic acid and Diltiazem, in terms of resolution and then validate the method by analyzing Carbamazepine, Terbinafine HCl & Atorvastatin Calcium. The compounds were analyzed with a total run time of 2.5min. (in reverse phase) at compound wavelength. Optimum retention was achieved on Waters Acquity UPLC BEH C18 column (2.1 × 30mm, 1.7μm) using gradient elution with 0.1% Trifluoro Acetic Acid in water (volatile ion pair reagent) and Acetonitrile as mobile phase. The developed method was validated with respect to specificity, linearity, precision, accuracy, ruggedness (reproducibility), robustness and stability. The method is economical in terms of the time taken and the amount of solvent used, thus promoting green chemistry concept. To the best of our knowledge, a work on method development and validation of Carbamazepine, Terbinafine HCl & Atorvastatin Calcium by using RP-UPLC technique, disclosed in this investigation, was not published elsewhere.
Keywords: Carbamazepine, Terbinafine HCl, Atorvastatin Calcium, Ultra Performance Liquid Chromatography, Liquid Chromatography-Mass Spectrometry (LCMS).
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