Method Development and Validation by RP-HPLC Analysis for Quantitative Estimation of Carbamazepine
Srujana Penumuru1, Gangadhara Ranga2, M. Indhu Priya3, Shobha Rani Tenkayala1*, Venkata Reddy Gorla4 & Ramachandra Bandi5The present study aimed to develop and verify a high-performance liquid chromatography technique for measuring Carbamazepine in formulations that suggest stability. The Waters Alliance 510 with UV–484 Data Ace software (Instrument I.D.: AL-011) and the Agilent 1100 Series with Chromeleon software (Instrument I.D.: AL-013) are the two HPLC systems used in this procedure. Tetra hydro furan, methanol, and water were used to form a new mobile phase with a volume ratio of 30:120:850 (V/V/V) and a rate of flow of 2 ml/min. The detection was done at 230 nm. Stress testing was performed on Carbamazepine to assess the stability-indicating nature of the process. This encompassed degradation by hydrolysis in acidic, basic, and neutral environments, UV deterioration, and thermal deterioration. A linear relationship was discovered (r2 = 0.999) for the concentration range of 50–150 ppm, which was further clarified by the regression equation Y=35.54x-254.8. Carbamazepine showed outstanding stability in conditions consisting of thermal, oxidative stress, acidity, base, and neutrality. The procedure's robustness, linearity, specificity, accuracy, and precision were all confirmed. The data demonstrate that it is suitable for commercial dosage form analysis in accordance with ICH guidelines since it is quick, accurate, precise, repeatable, and dependable.