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Research Article
Development and
Validation of a New RP-HPLC Method for the Determination
of Aprepitant in Solid Dosage Forms
Sreekanth Nama1*, Babu
R Chandu2,
Bahlul Z Awen2 and Mukkanti Khagga3
1Department
of Pharmacy, College of Public Health and Medical
Sciences, Jimma University, Jimma, Ethiopia, 2Al-Jabal
Al-Gharbi University, Al-Zawia, Libya, 3Centre
for Chemical Sciences and Technology, IST,
J.N.T.University, Kukatpally, Hyderabad, Andhrapradesh –
500 085, India.
For correspondence:
E-mail: sreekanthpharma@yahoo.co.in,
sreekanthnama@rediffmail.com,
sreekanthpharma@gmail.com Tel: +251917498574
Received: 29 November
2010 Revised
accepted: 27 June 2011
Tropical
Journal of Pharmaceutical Research, Aug 2011;
10(4): 491-497
http://dx.doi.org/10.4314/tjpr.v10i4.15
Abstract
Purpose:
To develop and
validate a new, simple, sensitive, rapid, cost-effective
and accurate reverse phase-high performance liquid
chromatography (RP-HPLC) method for the determination of
aprepitant (APT) in capsule dosage form.
Methods:
The method
developed for the determination of APT in capsule
formulation involved using RP-HPLC which incorporated a
C18 column 250 x 2.5 mm i.d, 5 µm particle
size, in isocratic mode, with mobile phase comprising of
methanol: water in the ratio of 90:10 (v/v). The flow
rate was 1 mL/min and the detection was monitored at 220
nm. The total run time was 10 min and the column was
maintained at ambient temperature.
Results:
APT was eluted
in the given mobile phase with a retention time (tr)
of 4.473 min. The linearity for the quantification of
APT was 0.1 - 10 µg/mL (R2 =0.989, Y= 33032x
+ 71501) with coefficients of variation (based on mean
peak area for six replicate injections) in the range
0.04 to 0.132. The limits of detection and of
quantification were 0.028 and 0.094 µg/mL, respectively.
Recovery of the method was 99.56 - 100.5 % while the
relative standard deviation (RSD) of intra-day and
inter-day precision was 0.85 and 1.05, respectively.
System precision and method precision were 0.013 and
1.400 %, respectively. The specificity data of the
proposed method indicated that excipients in the
capsules did not interfere with the drug peak.
Furthermore, the well-shaped peaks buttressed the
specificity of the method.
Conclusion:
The proposed
RP-HPLC method is simple, sensitive, rapid,
cost-effective and accurate for the determination of APT
in both bulk materials and pharmaceutical dosage forms.
Keywords:
Aprepitant, RP-HPLC, Isocratic, Pharmaceutical dosage
forms, Analysis, Validation. |
