STABILITY INDICATING UPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ALBUTEROL SULPHATE, THEOPHYLLINE AND BROMHEXINE IN BULK AND COMBINED DOSAGE FORMAbstract
A new simple, precise, accurate and selective UPLC method has been developed and validated for stability indicating UPLC method for simultaneous estimation of Albuterol sulfate, Theophylline and Bromhexine HCl in the tablet dosage form. The method was carried out on a Hibra C18, 250mm x 4.6mm, 5µm. a column with a mobile phase consisting of buffer and acetonitrile and buffer in the ratio of (55: 45 v/v/v) and flow rate of 1.0 ml/ min. The detection was carried out at 260nm. The retention time for Albuterol sulfate, Theophylline, and Bromhexine HCl were found to be 5.8, 2.3 and 9.7 min respectively. The method was validated according to the ICH guidelines for specificity, LOD, LOQ, precision, accuracy, linearity and robustness. The method showed good reproducibility and recovery with %RSD less than 2. So the proposed method was found to be simple, specific, precise, accurate and linear than the methods reported earlier. Hence, the method is economical, and it can be applied for routine analysis of Albuterol sulphate, Theophylline and Bromhexine HCl in bulk drug and pharmaceutical preparations. When applied for tablet assay, drug content was within the limits of the labelled content.
V. Padmaja * and M. Prasanthi
Department of Pharmaceutical Analysis, Nirmala College of Pharmacy, Atmakuru, Mangalagiri, Andhra Pradesh, India.
07 April 2018
21 March 2019
09 April 2019
01 May 2019