DEVELOPMENT AND VALIDATION OF THE HPTLC METHOD FOR THE SIMULTANEOUS ESTIMATION OF RAMIPRIL AND HYDROCHLOROTHIAZIDE IN SOLID DOSAGE FORMAbstract
Ramipril is an angiotensin-converting enzyme inhibitor and is used in treating high blood pressure. Hydrochlorothiazide is a diuretic drug that increases urine output. High-Performance Thin-Layer Chromatography is a sophisticated form of thin-layer chromatography which is a separation technique and is used in various bioavailability studies to study marketed formulations as well as novel therapeutic agents. We aimed to develop and validate a simple, precise, accurate, and rapid HPTLC method for the simultaneous estimation of Ramipril and Hydrochlorothiazide in the combined solid dosage form. Precoated silica gel G60F254 was used as the stationary phase. The mobile phase used was a mixture of methanol: toluene: ethyl acetate: glacial acetic acid (1:6:3:0.5 %v/v). Spot detection was carried out at 210 nm. Validation of the method was done in terms of linearity, accuracy, precision, and specificity. A linear calibration curve was obtained between 2000 to 12000 ng/spot for Ramipril and 500 to 3000 ng/spot for Hydrochlorothiazide. The limit of detection and the limit of quantification for the Ramipril was found to be 434.1 and 1315.483 ng/spot, respectively, and for Hydrochlorothiazide 80.6 and 244.31 ng/spot, respectively. The drug content of the marketed formulation was successfully determined by the proposed validate method.
Jyoti Verma and Sanjay Kumar Kushwaha *
Bhavdiya Institute of Pharmaceutical Sciences and Research, Ayodhya, Uttar Pradesh, India.
24 May 2023
27 January 2024
29 January 2024
01 February 2024