A VALIDATED STABILITY-INDICATING METHOD FOR DETERMINATION OF RELATED SUBSTANCES AND ASSAY OF PENCICLOVIR BY RP-UPLC IN PHARMACEUTICAL DOSAGE FORM
Sai Kumar B.*, Jyothi G., Sreenivasa Rao B.
ABSTRACT
A novel reverse-phase high performance liquid chromatography (HPLC) combined with photo-diode array detector method has been developed for determination of related substances (RS) in Penciclovir. The separation of penciclovir from its impurities has been successfully achieved using Kromasil C8 (150mm x 4.6 mm, 5µ) column maintained at 35oC±2oC. Due to longer runtime, development of an analytical method in ultra-performance liquid chromatography (UPLC) has been tried using Acquity UPLC column (100mm x 2.1mm, 1.7 µ). In optimized UPLC method, USP plate count is more and runtime is one fifth time lesser than HPLC method. The optimized UPLC method was validated with respect to specificity, accuracy, method precision, linearity, establishment of relative response factor (RRF) and limit of quantitation (LOQ), robustness, solution stability, forced degradation and filter validation studies. Same method was tested for determination of assay in UPLC using higher concentration of Penciclovir standard solution. Assay method was validated with respect to specificity, accuracy, method precision and linearity. It can be concluded that optimized UPLC method is suitable for determination of assay and related substances in Penciclovir with change in concentration of standard preparation.
Keywords: Reverse-phase HPLC, Reverse-phase UPLC, related substances, assay, method development, validation.
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