Derivative Spectrophotometric Methods for the Analysis and Stability Studies of Ranolazine in Bulk and Dosage Forms

Year 2022, Volume: 42 Issue: 1, 13 - 21, 01.03.2022

Noon Kmail Shaza Shantier , Elrasheed Gadkariem

https://doi.org/10.52794/hujpharm.1029049

Abstract

The present study was aimed to develop simple and accurate derivative spectrophotometric methods (1D and 2D) for the assay and stability studies of Ranolazine (RAN) in bulk and dosage forms. The methods were based on differentiating the original UV spectrum of RAN solution in methanol to generate the first and second derivative spectra which were measured at 278nm and 283 nm, respectively. The developed methods were then validated as per ICH guidelines and applied for the stability studies. Beer’s law was found to be valid over the concentration range100-600µg/ml with a correlation coefficient (r) not less than 0.999. The obtained limit of detection (LOD) and limit of quantification (LOQ) reflected the sensitivity of the methods (24.0 µg/ ml and 73.0 µg/ ml, 17.8 µg/ ml and 53.6 µg/ ml, for 1D and 2D, respectively). Good results were also obtained from the assay of RAN tablets (98.6 ± 2.3%, n=3). Studying the stability behavior of RAN using the developed methods reflects its instability under alkaline conditions following the first-order kinetics. The statistical validation at a 95% confidence level proves the sensitivity, precision, accuracy, and stability-indicating properties of the developed methods.

Keywords

Ranolazine, Spectrophotometry, ICH standards, Stability, Kinetics.

Ranolazinin Yığın ve Dozaj Formlarında Analizi ve Stabilite Çalışmaları için Türev Spektrofotometrik Yöntemler

Abstract

Bu çalışma, Ranolazine'in (RAN) yığın ve dozaj formlarında tahlil ve stabilite çalışmaları için basit ve doğru türev spektrofotometrik yöntemleri (1D ve 2D) geliştirmeyi amaçlamıştır. Yöntemler, sırasıyla 278 nm ve 283 nm'de ölçülen birinci ve ikinci türev spektrumlarını oluşturmak için metanol içindeki RAN çözeltisinin orijinal UV spektrumunun farklılaştırılmasına dayanıyordu. Geliştirilen yöntemler daha sonra ICH yönergelerine göre doğrulandı ve stabilite çalışmaları için uygulandı. Beer yasasının, 0,999'dan az olmayan bir korelasyon katsayısı (r) ile 100-600µg/ml konsantrasyon aralığında geçerli olduğu bulundu. Elde edilen saptama limiti (LOD) ve kantifikasyon limiti (LOQ), yöntemlerin duyarlılığını yansıtıyordu (sırasıyla 1D ve 2D için 24.0 µg/ml ve 73.0 µg/ml, 17.8 µg/ml ve 53.6 µg/ml). RAN tabletlerinin analizinden de iyi sonuçlar elde edildi (%98.6 ± 2.3, n=3). Geliştirilen yöntemler kullanılarak RAN'ın kararlılık davranışının incelenmesi, birinci dereceden kinetiği izleyen alkali koşullar altındaki kararsızlığını yansıtır. %95 güven düzeyindeki istatistiksel doğrulama, geliştirilen yöntemlerin duyarlılık, kesinlik, doğruluk ve kararlılık gösteren özelliklerini kanıtlar.

Keywords

Ranolazin, Spektrofotometri, ICH standartları, Kararlılık, Kinetik.

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