VALIDATION OF GAS CHROMATOGRAPHY (GC) METHOD FOR RESIDUAL SOLVENT IN BROMPHENIRAMINE MALEATE (API)Abstract
Active Pharmaceutical ingredient (API) of pharmaceutical bulk drug Brompheniramine Maleate (API) was validation by gas chromatography. Aim for this article was to check the Residual Solvents in Brompheniramine Maleate (API) by Gas Chromatographic technique. To validate a Gas Chromatographic method for detection and Quantification of Residual Solvents Methanol, Isopropyl Alcohol, DMSO and -O-Xylene. This technique was developed accurately, and validation parameters such as Accuracy, Specificity, Precision, Linearity and Range, Limit of detection (LOD), Limit of quantitation (LOQ), ruggedness, robustness and system suitability testing are explained. Gas chromatograph equipped with FID detector and headspace injection and column 30 m × 0.32 mm ID × 1.8 µm DB-624 capillary column with column temperature was 40 °C (hold 10 min) to 250 °C @ 40 °C/min, hold at 250 °C for 5 mins. Specificity was retention time for Methanol (2.13), Isopropyl Alcohol (3.45), DMSO (13.90), and -O-Xylene (13.74). The recovery for Methanol % RSD was 2.49, Isopropyl alcohol 1.18, and O-Xylene 1.91. All validation parameters are used in the routine and stability analysis.
S. B. Lakhmapure, S. Kothari and M. V. Lokhande *
Department of Chemistry, Sathaye College, Mumbai, Maharashtra, India.
16 October 2019
13 February 2020
11 March 2020
01 October 2020