Objective:
To develop an innovative, rapid, simple, cost
-effective
, stability indicating reverse phase
-high performance liquid chromatography (RP
-
HPLC) method for simultaneous estimation of ledipasvir (LP) and sofosbuvir (SB) in combination pill dosage form.
Method
s:
The method was developed using C8 column, 250
mm
x 4.6 mm, 5
mm
using mobile section comprising of 0.1%
(v/v)
orthophosphoric
acid buffer
at
pH 2.2
and acetonitrile in the ratio of 45:55 that was pumped through the column at a flow rate of 0.8 ml/min. Temperature
was
maintained at 30
°C, the effluents w
ere monitored at 260 nm with the help of usage of PDA detector.
Result
s:
The retention time of LP and SB were found to be 2.246 min and 3.502 min.
The approach was found to be linear with the variety of 9
-36
μg
/ml
and 40
-
240 μg
/ml
for LP and SB respectively, the assay of estimated compounds were found to be 99.65% and 99.73% w/v for LP and SB
respectively.
Conclusio
n:
The pressured samples changed into analyzed and this proposed a technique turned into determined to be particular and stability
indicating as no interfering peaks of decay compound and excipients were observed. Hence, the approach was easy and economica
l that may be
efficiently applied for simultaneous estimation of both LP and SB in bulk and combination tablet system