Spectrophotometric Analysis of an Injectable Combination Product by Partial Least Squares Regression


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ERTEKİN ÖZKAN Z. C., DİNÇ E.

EMU International Pharmaceutical Sciences Congress (IPSC 2025), Famagusta, Kıbrıs (Kktc), 14 Mayıs 2025, ss.23, (Özet Bildiri)

  • Yayın Türü: Bildiri / Özet Bildiri
  • Basıldığı Şehir: Famagusta
  • Basıldığı Ülke: Kıbrıs (Kktc)
  • Sayfa Sayıları: ss.23
  • Ankara Üniversitesi Adresli: Evet

Özet

Combination pharmaceutical products are widely used in both human and veterinary medicine. Ensuring their quality requires accurate and robust analytical methods that are preferably simple, low-cost and environmentally friendly. However, the simultaneous quantitation of multiple active compounds presents a challenge, especially in spectrophotometric analysis due to overlapping spectra.

The aim of this study was to develop a fast, accurate, and simple spectrophotometric method for the simultaneous quantitation of clorsulon and ivermectin in a veterinary injectable formulation, without requiring separation steps or complex sample preparation.

The injectable combination of clorsulon and ivermectin is used in cattle to treat internal and external parasites. As their UV spectra overlap extensively, their spectrophotometric analysis requires the use of a suitable chemometric model. In this work, a partial least squares (PLS) regression model was developed using a training set of 25 binary mixtures of ivermectin (3.0–40.0 µg/mL) and clorsulon (2.5–36.0 µg/mL), designed via a 5² factorial design. The model was constructed using absorbance data in the 200–350 nm range (601×25 matrix) and corresponding concentration data (2×25 matrix). Cross-validation procedure indicated that three latent variables were optimal for both analytes.

Analytical method validation was performed by analyzing independent test mixtures in various concentrations, as well as intra-day, inter-day and standard addition samples. Recovery results for ivermectin and clorsulon in the test set were reported to be 100.11% and 101.38%, respectively. After validation, the model was applied to commercial injectable formulations, resulting in mean assay values of 10.25 mg/mL for ivermectin and 98.95 mg/mL for clorsulon, consistent with the labeled content.