STABILITY INDICATING RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF SALBUTAMOL AND BECLOMETHASONE IN BULK AND TABLET DOSAGE FORMAbstract
A new, simple, sensitive, precise, accurate and stability indicating RP-HPLC method has been developed for the simultaneous estimation of salbutamol and beclomethasone in combined tablet dosage form. The analysis was carried out at 230 nm and this chromatographic separation was achieved with Kromasil 250 C18 [250 x 4.6 mm, 5µ] column under 25 oC temperature and using mobile phase water and acetonitrile in a ratio of 55:45 v/v adjusted pH 2 with ortho phosphoric acid. The retention times of salbutamol and beclomethasone were found to be 2.030 ± 0.01 min, 3.271 ± 0.1min respectively. The proposed method was validated according to ICH guidelines. The linearity study of salbutamol and beclomethasone was found in concentration range of 25 – 150 µg/ml and 50 – 300 µg/ml and correlation coefficient (r2) was found to be 0.999 and 0.999. The percentage recovery was obtained as 98.61 % and 100.75 % w/v for beclomethasone and salbutamol. The LOD, LOQ values were obtained from regression equations of beclomethasone and salbutamol were 1.13 µg/ml, 2.06 µg/ml and 3.42 µg/ml, 6.23 µg/ml respectively. The studies were carried out by conducting deliberate degradation of the sample with exposure to stress conditions like acidic (1M HCl), alkaline (1M NaOH), thermal, oxidizing agents (H2O2) and water. This method was validated and met the regulatory requirements for specificity, Linearity, LOD, LOQ, Precision, accuracy and stability for the determination of salbutamol and beclomethasone in bulk and tablet dosage form by RP-HPLC.
N. Abbai * and S. A. Parameswari
Department of Pharmaceutical Analysis, Krishna Teja Pharmacy College, Tirupathi, Andhra Pradesh, India.
31 July, 2017
30 October, 2017
27 January, 2018
01 May, 2018