Aim: This study was designed to develop a reliable method for the estimation of 3TC, TFV, and EFV in pure and its pharmaceutical dosage form by RP-HPLC.
Background: An easy, defined, rapid, and accurate
reverse-phase high-performance liquid chromatography method was developed and
subsequently validated for the concurrent estimation of lamivudine, efavirenz,
and tenofovir disoproxil fumarate in their pure blend and combined tablet
formulation.
Methods: A simple, rapid, accurate, precise, robust, and
isocratic reverse-phase high-performance liquid chromatographic (RP-HPLC)
method was developed for the estimation of 3TC, TFV, and EFV in a combined
dosage form. The method was developed by using Inertsil ODS-3V (250 × 4.6, 5
µm) column, with Mobile phase composition of Acetonitrile: 1% IPA in the ratio
of 85:15 at a flow rate of 1 ml/min and the effluents were monitored at 256 nm
using PDA detector.
Results: 3TC, TFV, and EFV drugs were eluted at retention
times of 2.4, 2.8, and 4.5 min (± 0.5). The proposed method was validated as
per ICH guidelines. The correlation coefficient (R2) was found to be 0.999. All
the parameters were found to be within the limits. The recovery studies were
carried out and found to be within 98-102% and the %RSD was found to be <2%.
The limit of Detection and Limit of Quantification of 3TC, TFV, and EFV were
found to be 0.06, 0.09, 0.17 µg/ml and 0.18, 0.27, 0.53 µg/ml respectively. The
results obtained are in good agreement and can be used for the routine analysis
of drugs in combined dosage form in laboratories and for Quality control
purposes.
Conclusion: The present method was developed and validated
using 1% IPA: ACN. IPA enhances the selectivity of binary or tertiary mixtures.
The main reason for the use of IPA as a part of the aqueous mobile phase is to
keep the column free of undesired adsorbed contaminants from the sample or a
sample matrix. This may change the retention behaviour of the analyte or as a
baseline noise or drift. By using IPA which acts as a good washing agent of the
column when compared to other solvents. The proposed method has a shorter
analysis time, which allows it to be applied to several samples in less time.
As a result, the proposed method was discovered to be unique, simple, accurate,
and resilient, and validation experiments revealed that the proposed methods
are adequate for routine quality analysis of the combination dosage form.
Author (s) Details
L. Siva Shankar Reddy
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy,
Nandyal-518501, Andhra Pradesh, India.
D. Madhuri
Department of Pharmaceutical Analysis, Creative Educational Society's
College of Pharmacy, Kurnool-518001, Andhra Pradesh, India.
N. Madana Gopal
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy,
Nandyal-518501, Andhra Pradesh, India.
J. Kumar Raja
Department of Pharmaceutical Analysis, Mother Teresa College of Pharmacy,
Kothuru, Sanketika Nagar, Sathupally, Telangana 507303, India.
V. Ravikumar
Department of Pharmaceutical Biotechnology, School of Pharmacy, Guru Nanak
Institutions Technical Campus, Hyderabad, Telangana, India.
B. Himabindu
Department of Pharmaceutical Analysis, Creative Educational Society's
College of Pharmacy, Kurnool-518001, Andhra Pradesh, India.
R. Nageswara Rao
Department of Pharmaceutical Analysis, Santhiram College of Pharmacy,
Nandyal-518501, Andhra Pradesh, India.
Please see the book here:- https://doi.org/10.9734/bpi/prrat/v6/2088
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