World Journal of Current Medical and Pharmaceutical Research

Heavy metal analysis, pesticide residue analysis and aflatoxin assay of siddha herbal formulationmadhumega nivarani chooranam

Suresh Balaji N — 2023-11-26

Aim

The aim of the study was to assess the Heavy metal analysis, pesticide residue and aflatoxin assay of Siddha herbal formulation “Madhumega Nivarani Chooranam”, used for the management of Madhumegam (Type-II Diabetes mellitus)

Materials and Method

According to the procedure that is stated in the Siddha text "The Pharmacopoeia of Siddha Research Medicines," the siddha poly herbal formulation was formulated in accordance with good manufacturing practises (GMP) regulations. Aflatoxin assay, pesticide residue analysis, and heavy metal analysis these studies were all carried out at Nobel Research Solutions in Chennai.

Results

The above assay, which used AAS to identify Heavy metals in the siddha medicine Madhumega Nivaran iChooranam revealed BDL (below detective level), presence of lead and arsenic at 1.14 PPM and 0.34 PPM level as listed in the table. The study revealed absence of Aflatoxin and pesticide residues in the given sample. It is indicating that this drug is safe to use.

Conclusion

According to the results, the sample Madhumega Nivarani Chooranam (MNC) has been determined to be safe throughout the present screening process, with the presence of heavy metals below the detection limit, Devoid of aflatoxins, as well as Residues of Pesticides. Hence, the current study reveals the drug was safe for therapeutic use

Development and Validation of RP-HPLC method for the estimation of Plecanatide from Bulk and Pharmaceutical Dosage form

Vasala Deepika — 2023-12-01

A novel, simple, efficient, rapid, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed for the estimation of Plecanatide in the bulk and pharmaceutical dosage form. The currently developed method was subsequently validated according to ICH guidelines in terms of linearity, accuracy, precision, the limit of detection, the limit of quantification, robustness, etc. The separation of the selected drugs was optimized after several trials including change of mobile phase and its composition, stationary phase, flow rate, column temperature, etc. The separation was performed by using an Develosil ODS HG-5 and UV absorption was measured at 246 nm. Ortho phosphoric acid, Triethylamine buffer : Methanol [520 : 480] was selected as the mobile phase at a flow rate of 1 mL/min. As per International Conference on Harmonization (ICH) Q2 R1 guidelines, several validation parameters were evaluated which include specificity, linearity, precision, accuracy, the limit of detection (LOD), and the limit of quantitation (LOQ). The acceptable degree of linearity range was found to be 10 to 60 µg/mL. The percent recovery was found to be 98.55 to 101.88%. Hence, the proposed method is simple, selective, and specifically meets the requirements of ICH guidelines for the validation of the analytical method.