DEVELOPMENT AND VALIDATION OF STABILITY INDICATING UPLC METHOD FOR THE DETERMINATION OF RELATED SUBSTANCES IN VALACYCLOVIR HCL DRUG SUBSTANCE
Tene Sivaganesh, Tirukkovalluri Siva Rao*, Kommula Ramasrinivas, Uppalapu Sesham Raju, Arun Mendiratta and Raja Gorla
ABSTRACT
Method development, validation and stability indicating RP-UPLC method for the determination of Valacyclovir HCl and its related substances in pharmaceutical products. This method has high degree of performance to separation and quantification of Valacyclovir HCl in the presence of its related substances. This efficient Separation can be achieved by using new Waters Acquity CSH Phenyl hexyl with dimensions (100mm x 2.1 mm, 1.7μm). The buffer used in this method Trifluro Acetic Acid with a flow rate of 0.3 ml/min and the absorbance was monitored at 254 nm. The total run time was 10.0 min. The correlation coefficient of the method shows good linear relationship with 0.998 to 0.999 for all related substances. The limit of detection and quantification are determined for Valacyclovir HCl related substances are 0.01μg/ml and 0.03μg/ml .The signal to noise ratio has been observed about 3 and 10 for LOD & LOQ for all related substances. The precision of the method %RSD is less than 6.4% and the % recovery of Valacyclovir HCl and its related substances is between 80.1 – 116 %.When the drug is subjected to different stress conditions and the resulting degradation products obtained were not interfere during the determination of Valacyclovir HCl and its related substances.
Keywords: Valacyclovir HCl, RP-UPLC, Method development, Validation, Stability-indicating.
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