Low level detection of p-Toluene sulfonic acid in Valganciclovir hydrochloride by RP-HPLC method

The present work describes the development of a reverse phase high performance liquid chromatographic (RPHPLC) method for the quantification of p-Toluenesulfonic acid in Valganciclovir hydrochloride. The drug substance was subjected to stability studies using optimized method condition to enhance low level of detection with minimum acquisition time. Successful separation of p-Toluenesulfonic acid was achieved from the related impurities of the drug on an Inertsil ODS-3V (150 x 4.6mm) 5μm column. The gradient LC method employs solution A and solution B as mobile phase. The solution A contains 0.1% OPA and solution B contains Acetonitrile. The HPLC method was developed and validated to prove its performance characteristics by demonstrating selectivity, sensitivity (limit of detection and quantification), linearity, accuracy, precision and ruggedness

Author(s): T.Kaleemullah, Mansur Ahmed , Hemant Kumar Sharma

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