Comparative Analytical Evaluation of Khadira Leha and Its Modified Granules

Background: Khadira Leha is an Ayurvedic semisolid dosage form in which pharmaceutical processing influences moisture content, extractive values, sugar profile and other quality attributes. In the present work, Khadira Leha was modified into a granule dosage form by Khanda Paka and both formulations were subjected to comparative analytical evaluation.Objectives: To evaluate and compare the organoleptic, physico-chemical, chromatographic, GC-MS and microbial characteristics of Khadira Leha and its modified granules.Methods: The prepared Khadira Leha and granules were evaluated for organoleptic characters, loss on drying, total ash, acid-insoluble ash, pH, water-soluble extractive, alcohol-soluble extractive, total sugar, reducing sugar, non-reducing sugar and total solids. Granules were additionally assessed for bulk density, tap density and compressibility. Thin Layer Chromatography (TLC), Gas Chromatography-Mass Spectroscopy (GC-MS), and microbial load analysis for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mould Count (TYMC) were performed.Results: Khadira Leha showed LOD 10.64%, total ash 1.60%, acid-insoluble ash 0.80%, pH 5.05, water-soluble extractive 68.99%, alcohol-soluble extractive 19.13% and total solids 89.36%. Granules showed corresponding values of 3.16%, 1.67%, 0.10%, 5.14, 75.72%, 41.84% and 96.84%. The total sugar contents were 32.86% and 32.02%, respectively. TLC showed comparable Rf patterns. GC-MS identified 2-(Isobutoxymethyl)oxirane as the major reported peak in both formulations, with area 50.99% in Leha and 62.14% in granules. TAMC was <10³ CFU/g and TYMC was <10² CFU/g in both formulations.Conclusion: The analytical profile of the modified granules remained broadly comparable with Khadira Leha, while the granules exhibited lower moisture content and higher total solids and extractive values. The findings support analytical comparability of the two dosage forms within the parameters studied.