Marker assay guided standardization of an ayurvedic concentrated polyherbal decoction “CiruvilvāDi KaṣāYam” and its application in industrial quality control

Abstract

Background: To establish a marker guided standardization technique to assess whether the marketed concentrated kaṣāyam (decoction) prepared in large scale is providing the same phytochemical values of a Laboratory Reference Standard (LRS) kaṣāyam prepared classically from raw materials of Pharmacopoeial quality. Objectives: Manufacturing and standardization of LRS 'Ciruvilvādi kaṣāyam', including marker assays and its comparison with four different marketed samples. Materials and Methods: pH, Brix and Total solids of samples were determined and compared. HPTLC profile comparison and quantitative comparison with HPLC were done with Gallic acid and Piperine as standards. Results and Conclusion: Results of Brix and Total solids imply that, the manufacturing process of sample IV was significantly different from other samples and LRS. pH value of sample III showed a significant difference as compared to other samples and LRS, indicating a difference in phytochemical contents. Quantification of Piperine and Gallic acid revealed that sample III has a very low Gallic acid concentration and zero Piperine concentration. Sample IV showed a very high concentration of Gallic acid when compared to other samples and LRS. Sample I, II and IV had piperine content but significantly lower when compared to the LRS. In conclusion, the samples (1-IV) which showed difference with the LRS should be made phytochemically comparable to in-house LRS or Pharmacopoeial standards by adopting the marker assay standardization technique. This method helps to identify and rectify the problems related to raw material, in process and finished product quality control.