RP-HPLC Method Development and Validation for the Estimation of Pregabalin and Methylcobalamin in Formulation

Autor: Padala Alekya, S. Akanksha, K. Anusha, Upendra Udiyana, Suresh Vanapalli, Naveen Sarakana, D. Komali, Jagadeesh Panda
Rok vydání: 2022
Předmět:
Zdroj: International Journal of Pharmaceutical Sciences Review and Research. :48-53
ISSN: 0976-044X
DOI: 10.47583/ijpsrr.2022.v74i02.007
Popis: By considering the current regulatory requirement for an analytical method development, a reversed phase high performance liquid chromatographic method for routine analysis of pregabalin and Methylcobalamin has been developed . The optimized method was achieved using unisol C-18 (3 μm, 4.6 ×150 mm) column with mobile phase consisting of mixture of water and methanol (40: 60 v/v) with a flow rate of 0.6ml/min at 210 nm. The optimized method was then validated according to the ICH guidelines. The developed method was found linear over the concentration range of 50-150 μg/ml for pregabalin and 5-15 μg/ml for Methylcobalamin and the detection and quantitation limit was found to be 2.69μg/ml ,8.18 μg/ml for pregabalin and 1.74μg/ml, 5.27μg/ml for Methylcobalamin respectively. Therefore, a sensitive, robust, accurate method was developed with high degree of practical utility.
Databáze: OpenAIRE