Development and Validation of Novel Rp-HPLC Method for Simultaneous Estimation of Gabapentin and Amitriptyline Hydrochloride in Bulk and Pharmaceutical Dosage Forms

Abstract

Objective: To develop a novel, accurate, precise and linear reverse phase high performance liquid chromatographic (RP-HPLC) method for simultaneous quantitative estimation of gabapentin and amitriptyline hydrochloride in gabantip-at tablet and validate as per international conference on harmonization (ICH) guidelines and to perform the force degradation studies using the developed method.Methods: In the present work, good chromatographic separation was achieved isocratically using a shim-pack HPLC C18 column (4.6 x 250 mm, 5μm) and mobile phase consisting of 0.05 M potassium dihydrogen orthophosphate pH 2.1 adjusted with orthophosphoric acid and acetonitrile in the ratio (55:45), at flow rate 1 ml/min and column temperature (25 °C). The effluents obtained were monitored at 221 nm with the UV-visible detector.Results: The retention time of gabapentin and amitriptyline hydrochloride was found to be 1.959 min and 4.221 min respectively. The linearity of gabapentin was found in the range of 720-1680 ppm and that for amitriptyline hydrochloride was found to be 24-56 ppm. The correlation coefficient for gabapentin and amitriptyline hydrochloride were 0.999 and 0.9963 respectively. The high recovery values (98%-101%) indicate a satisfactory accuracy. The low percent relative standard deviation (% RSD) values in the precision study reveals that the method is precise.Conclusion: The developed method is novel, simple, precise, rapid, accurate and reproducible for simultaneous estimation of gabapentin and amitriptyline hydrochloride tablet dosage form. Hence the proposed method may find practical applications as a quality-control tool in the simultaneous analysis of the two drugs in combined dosage forms in quality-control laboratories.

Method Development, Validation and Stability Studies for the Determination of Lurasidone Hydrochloride in Bulk and Tablet Dosage Form by Rp-HPLC

“…The proposed method was validated [15][16][17][18][19] for specificity, linearity, accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), robustness and system suitability as per international conference on harmonization (ICH) guidelines.…”

Retention behaviour of analytes in reversed‐phase high‐performance liquid chromatography—A review

“…Clonazepam and propranolol hydrochloride were eluted with acetonitrile and 0.01 M ammonium phosphate buffer (pH 3.0) adjusted with orthophosphoric acid by Meghana et al (2012), whereas methanol, acetonitrile and 20 mM potassium dihydrogen phosphate buffer were utilized as an eluent by Annapurneswari to analyse the same (Annapurneswari et al, 2012). In this aforementioned chromatographic condition, the retention of propranolol is governed by its degree of ionization and the retention of clonazepam is governed by its interaction with the anionic chaotrope.…”

Kajian Potensi Inkompatibilitas dan Instabilitas: Studi Kasus Sediaan Racikan Mengandung Amitriptilin, Trifluoperazine Dihidroklorida dan Alprazolam

“…Kelembaban dalam serbuk tidak boleh dianggap remeh karena dapat memicu pertumbuhan mikroba, mengurangi estetika, dan merusak bahan aktif. Diketahui bahwa AMT dan ALP berpotensi mengalami hidrolisis karena pengaruh lembab (Castañeda et al, 2009;Gonsalves et al, 2010;Shaikh and Jain., 2018). Potensi hidrolisis semakin meningkat karena berdasarkan data BMKG Jawa Tengah (2019), RH rata-rata di Kota Semarang berkisar antara 60-95%, yang berati kelembaban udara tinggi.…”