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ABSTRACT :
The analytical method validation was simple, efficient, and less time-consuming for simultaneous estimation of alpha-calcidol capsules by HPLC. Chromatographic separation was accomplished in the isocratic mode. Mix 920 volumes of n-Hexane, 40 volumes of IPA, 40 volumes of tetrahydrofuran, and 2 volumes of acetic acid (920:40:40:2) in a 1000-mL beaker and mix well, then sonicate for 5 minutes as the mobile phase by using the column Thermo Scientific silica, 250 x 4.6 mm, 3µm, or equivalent as the stationary phase with a flow rate of 2.0 ml/min using an UV detector maintained at 265 nm. The reported periods of retention time of alfacalcidol were found to be 9.4 minutes. As per ICH guidelines, this procedure has been validated for specificity, linearity and range, accuracy, system precision, method precision, intermediate precision, robustness, solution stability, and filter integrity.
Keywords:
Keywords: HPLC, Alfacalcidol, ICH guidelines. Method Validation
Cite Article:
"ANALYTICAL METHOD VALIDATION FOR IDENTIFICATION AND ASSAY OF ALFACALCIDOL IN ALFACALCIDOL SOFT GELATIN CAPSULES BY HPLC ", International Journal of Science & Engineering Development Research (www.ijrti.org), ISSN:2455-2631, Vol.9, Issue 6, page no.447 - 459, June-2024, Available :http://www.ijrti.org/papers/IJRTI2406063.pdf
Downloads:
000205086
ISSN:
2456-3315 | IMPACT FACTOR: 8.14 Calculated By Google Scholar| ESTD YEAR: 2016
An International Scholarly Open Access Journal, Peer-Reviewed, Refereed Journal Impact Factor 8.14 Calculate by Google Scholar and Semantic Scholar | AI-Powered Research Tool, Multidisciplinary, Monthly, Multilanguage Journal Indexing in All Major Database & Metadata, Citation Generator