Journal article Open Access

DEVELOPMENT AND VALIDATION FOR ESTIMATION OF CLINDAMYCIN, ADAPALENE AND SOFOSBUVIR IN BULK AND PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC METHOD

G. Swathi*, G.Deepthi , Deepthi Visakh, J. Prathyusha, Nafees Fatima, M. Sai lakshmi

A simple, accurate, rapid and precise isocratic stability indicating reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of Clindamycin and Adapalene in tablets. The chromatographic separation was carried out on C18 BDS Hypersil (150 x 4.6mm, 5µ)   with a mixture ofmixed phosphate buffer : acetonitrile (55:45%v/v)  as a mobile phase at a flow rate of 1.0mL/min. UV detection was performed at 230nm. The retention times were2.84 and 3.999min for Clindamycin and Adapalene respectively. Calibration plots were linear (r2=0.999) over the concentration range of 25-150µg/mL for Clindamycinand2.5-15µg/mL for Adapalene. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Clindamycin and Adapalene in bulk and tablet dosage form.

Sofosbuvir is used primarily to treat hepatitis C and viral hemorrhagic fevers. It is possible to select a sofosbuvir resistant mutant of HCV that can replicate to levels similar to wild type virus grown without sofosbuvir. Analysis of the mutations responsible for the sofosbuvir resistance may aid in understanding the mechanism of action of sofosbuvir.

Keywords: Clindamycin , Adapalene, RP-HPLC, Tablets, hepatitis C.

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