A straightforward, precise, and reversed-phase
high-performance liquid chromatographic (RP-HPLC) method has been developed and
validated for the simultaneous quantification of EMPA, LINA, and MET in
pharmaceutical dosage forms. Chromatographic separation was conducted using an
Eclipse XDB C18 Column (250 mm × 4.6 mm i.d., particle size 5 µm, maintained at
ambient temperature), with a mobile phase consisting of 0.01 N KH2PO4 and
acetonitrile in a 50:50 v/v ratio. A pH 5.3 buffer, adjusted with o-phosphoric
acid, was utilized. UV detection was carried out at 220 nm, and the retention
times were 2.767, 2.362, and 3.276 minutes for EMPA, LINA, and MET,
respectively. Calibration plots demonstrated linearity (r2 > 0.999) over the
concentration range of 2.5-15 µg/mL for EMPA, 1.25-7.5 µg/mL for LINA, and
250-1500 µg/mL for MET. The method underwent rigorous validation for accuracy,
precision, specificity, linearity, and sensitivity. Successfully applied to the
quantitative analysis of pharmaceutical dosage forms, the method exhibited no
interference from any component of the pharmaceutical dosage form.
Validation studies affirmed the specificity, rapidity, reliability, and
reproducibility of the method. High recovery and low relative standard
deviation further affirmed the method's suitability for the routine
determination of EMPA, LINA, and MET in pharmaceutical dosage forms.
Author(s) Details:
Panchumarthy Ravisankar,
Department of Pharmaceutical Analysis, Vignan Pharmacy College,
Vadlamudi, Guntur District – 522 213, Andhra Pradesh, India.
Ch.
V. Prasada Rao,
Department
of Pharmaceutics, Vignan Pharmacy College, Vadlamudi, Guntur, District – 522
213, Andhra Pradesh, India.
Please see the link here: https://stm.bookpi.org/ACPR-V6/article/view/13416
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