Abstract

Divya-Swasari-Vati (DSV) is a calcium-containing herbal medicine formulated for the symptomatic control of respiratory illnesses observed in the current COVID-19 pandemic. DSV is an Ayurvedic medicine used for the treatment of chronic cough and inflammation. The formulation has shown its pharmacological effects against SARS-CoV-2 induced inflammation in the humanized zebrafish model. The present inventive research aimed to establish comprehensive quality parameters of the DSV formulation using validated chromatographic analytical tools. Exhaustive identification of signature marker compounds present in the plant ingredients was carried out using ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC/QToF MS). This was followed by simultaneous estimation of selected marker components using rapid and reliable high-performance liquid chromatography (HPLC) analysis. Eleven marker components, namely gallic acid, protocatechuic acid, methyl gallate, ellagic acid, coumarin, cinnamic acid, glycyrrhizin, eugenol, 6-gingerol, piperine and glabridin, were selected out of seventy-four identified makers for the quantitative analysis in DSV formulation. Validation of the HPLC method was evaluated by its linearity, precision, and accuracy tests as per the International Council of Harmonization (ICH) guidelines. Calibration curves for the eleven marker compounds showed good linear regression (r2 > 0.999). The relative standard deviation (RSD) value of intraday and interday precision tests were within the prescribed limits. The accuracy test results ranged from 92.75% to 100.13%. Thus, the present inclusive approach is first of its kind employing multi-chromatographic platforms for identification and quantification of the marker components in DSV, which could be applied for routine standardization of DSV and other related formulations.

Highlights

  • The world community is grappling with the devastating effects of the novel coronavirus disease (COVID-19) caused by Severe Acute Respiratory Syndrome Corona Virus2 (SARS-CoV-2)

  • The results provided evidence that the established highperformance liquid chromatography (HPLC) method is accurate for the simultaneous determination of eleven marker components in DSV (Table 3)

  • The results provided evidence that established HPLC–DAD method is accurate for simultaneous estimations of gallic acid, protocatechuic acid, methyl gallate, ellagic acid, coumarin, cinnamic acid, glycyrrhizin, eugenol, 6-gingerol, piperine and glabridin in DSV

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Summary

Introduction

The world community is grappling with the devastating effects of the novel coronavirus disease (COVID-19) caused by Severe Acute Respiratory Syndrome Corona Virus2 (SARS-CoV-2). The world community is grappling with the devastating effects of the novel coronavirus disease (COVID-19) caused by Severe Acute Respiratory Syndrome Corona Virus. The pandemic has caused a serious medical crisis, infecting more than 120 million people and leading to more than 2 million deaths [1]. The situation is considered to be more serious for patients suffering from respiratory syndromes. Infection with this respiratory virus is associated with robust inflammatory responses, which further worsen the condition [2]. The immune system plays an essential role in COVID-19 infection. Enhancing the (natural body system) immunity may represent a major contribution as a prophylactic measure against multiple pathogenic conditions as well as maintaining optimum health [3]

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