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DEVELOPMENT AND VALIDATION OF NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ELBASVIR AND GRAZOPREVIR IN BULK AND PHARMACEUTICAL DOSAGE FORM

Dandu Girijaa* and Basu Venkateswara Reddyb

*a Department of Pharmaceutical Analysis, b Department of Pharmaceutics, Sankar Reddy Institute of Pharmaceutical sciences, Salakalveedu (v), Bestavaripeta (M), Prakasam (DT) Andhra pradesh - 523370.

* For correspondence E-mail: girija.dandu@gmail.com


ABSTRACT

The present study describes the development and validation of a new stability indicating RP-HPLC method for simultaneous estimation of elbasvir and grazoprevir in bulk and pharmaceutical dosage form. The chromatographic separation was done by using reverse phase YMC column (4.6 x 250mm, 5μm).The mobile phase used was mixture of HPLC grade water acetonitrile (70:30V/V) at flow rate of 1ml/ min in isocratic mode and detection was carried out using PDA detector at 244nm.The developed method showed a good linearity in the range of 100-500μg/mL for elbasvir and 200-1000 μg/mL for grazoprevir with regression co-efficient of 0.999 for both the drugs. The % recovery of drugs was found to be 100.1% for elbasvir and 100.38% for grazoprevir. The proposed stability indicating method was accurate, precise, robust, stable and specific. The developed method was validated in accordance with ICH guidelines.

Year 2020 | Volume No. 57 | Issue No.9 | Page No. 53-59
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