DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD OF ACEBUTALOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE IN BULK AND TABLET DOSAGE FORM Authors: Pawar SM , JADHAV S AND TAMBOLI A
ABSTRACT
There is not a singal analytical methods appeared in the literature for the determination of
Acebutalol Hydrochloride and Hydrochlorothiazide in combine tablet dosage form. Attempts
were made to develop RP-HPLC method of Acebutalol Hydrochloride and
Hydrochlorothiazide in bulk drug and Sectrazide tablet formulation. RP-HPLC method was
developed and validated as per ICH guidelines using Column C18 (4.6mm x 250mm) and
Acetonitrile:Phosphate buffer (pH 2.5) in the ratio 85:15 as mobile phase. Retention time of
Acebutalol Hydrochloride and Hydrochlorothiazide was found to be 3.07 and 4.43 mins
respectively at the wavelength 230nm and flow rate 1.0ml/min. Acebutalol Hydrochloride
(Acbtl) and Hydrochlorothiazide (Hctz) individually follows the Beer-Lamberts law over
concentration range 5-25?g/ml and 2-10 ?g/ml regression of coefficient was found to be
r
2=0.998 and r2=0.999 respectively. The percentage recovery was found in the range of 98%
to 102% at three different levels. The method was found to simple yet accurate, precise and
reproducible and successfully applied for the routine quality control analysis of Acebutalol
Hydrochloride and Hydrochlorothiazide in bulk drug as well as in tablet formulation as per
ICH guidelines. The result of the analysis were validated statistically and were found to be
satisfactory.
Keywords: Acebutolol Hydrochloride, Hydrochlorothiazide, Simultaneous equation, HPLC, UV
Spectrophotometer
Publication date: 01/11/2022 https://ijbpas.com/pdf/2022/November/MS_IJBPAS_2022_6584.pdfDownload PDFhttps://doi.org/10.31032/IJBPAS/2022/11.11.6584