DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR THE ESTIMATION OF ACTIVE INGREDIENTS IN XTEE HB TABLETS
DOI:
https://doi.org/10.22159/ijap.2026v18i2.57415Keywords:
XteeHb, Ferric pyrophosphate (FPP), High-performance liquid chromatography (HPLC), Ultraviolet–visible (UV–Vis) spectrophotometry, Vitamins, Method validation, International council of harmonization (ICH) guidelinesAbstract
Objective: To develop and validate robust analytical methods for the quantification of ferric pyrophosphate (FPP), ascorbic acid (vitamin C), cyanocobalamin (vitamin B12), and folic acid (FA) in XteeHb tablets, addressing the analytical challenges posed by their diverse physicochemical properties.
Methods: Separate reversed-phase high-performance liquid chromatography (HPLC) methods were optimized and validated for ascorbic acid (vitamin C), cyanocobalamin (vitamin B12), and folic acid (FA), while ferric pyrophosphate (FPP) was quantified using a validated ultraviolet–visible (UV–Vis) spectrophotometric assay due to its inorganic nature and poor chromatographic response. Validation was performed in accordance with ICH Q2(R1) guidelines, assessing specificity, linearity, precision, accuracy, robustness, and forced degradation.
Results: All methods demonstrated excellent linearity (R² ≥ 0.999), precision (% RSD<2 %), and recovery values within 98–102 %. System suitability parameters met acceptance criteria for all analytes. Assay testing of marketed XteeHb Tablets showed compliance with specification limits (≥ 90 % of label claim), with no interference from excipients. The ultraviolet–visible (UV–Vis) method showed stable and reproducible absorbance for iron detection at 540 nm.
Conclusion: The validated analytical approaches are accurate, precise, and suitable for routine quality control, batch release, and stability monitoring of multicomponent hematinic formulations. This multi-method strategy provides a reliable framework to ensure the pharmaceutical quality of XteeHb Tablets and similar iron–vitamin supplements.
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