Journal of PharmTechNova
Short Name: JPTN• ISSN: 3139-9258• Peer-Reviewed Open Access
RP-HPLC Method Development and Validation for Simultaneous Estimation of Amitriptyline and Frovatriptan in Bulk and Pharmaceutical Dosage Forms
Abstract
An easy, rapid, and reliable reverse phase high performance liquid chromatographic (RP-HPLC) approach was devised and validated for the simultaneous estimation of Amitriptyline and Frovatriptan in bulk and pharmaceutical dosage forms. Chromatographic separation was successfully attained through an Inertsil C18 column (4.6 × 150 mm, 5 µm) packed with chemically bonded porous silica particles as the stationary phase. The optimized mobile phase consisted of methanol and phosphate buffer (pH 3.0) in the ratio of 70:30 % v/v, delivered at a constant flow rate of 0.8 mL/min. Detection was carried out at 260 nm using a UV detector. The method demonstrated excellent linearity over the concentration range of 100–500 µg/mL for Amitriptyline and 1–5 µg/mL for Frovatriptan, using correlation values close to 0.999, indicating strong proportionality between concentration and peak area. Precision studies showed percentage comparative standard deviation ranges beneath 2%, confirming good repeatability and consistency. Accuracy was evaluated by recovery studies, and percentage recoveries were found within the acceptable range of 98–102% for both drugs. The limits of detection and quantification were within acceptable limits, reflecting adequate sensitivity of the developed method. All validation parameters complied with ICH and USP guidelines, confirming the specificity, accuracy, precision, linearity, and robustness of the approach. Consequently, the suggested RP-HPLC technique utilizing an Inertsil C18 column is appropriate for standard quality control assessment of Amitriptyline or Frovatriptan in pharmaceutical formulations with high reliability and reproducibility.
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