Development and Validation of Stability-Indicating RP-UPLC Method for the Determination of Methdilazine in Bulk Drug and in Pharmaceutical Dosage Form

Abstract

A simple, precise, and accurate, and stability-indicating isocratic Ultraperformance Liquid Chromatography (UPLC) method was developed for the determination of methdilazine hydrochloride (MDH) in bulk drug and in its tablets. The use of UPLC, with a rapid 5-minute-reversed-phase isocratic separation on a 1.7 µm reversed-phase packing material to provide rapid "high throughput" support for MDH, is demonstrated. The method was developed using Waters Acquity BEH C18 column (100 mm × 2.1 mm, 1.7 µm) with mobile phase consisting of a mixture of potassium dihydrogenorthophosphate and 1-pentane sulphonic acid buffer of pH 4.0 and acetonitrile (60 : 40 v/v). The eluted compound was detected at 254 nm with a UV detector. The standard curve of mean peak area versus concentration showed an excellent linearity over a concentration range 0.5-80 µg mL −1 MDH with regression coefficient (r) value of 0.9999. The limit of detection (S/N = 3) was 0.2 µg mL −1 and the limit of quantification (S/N = 10) was 0.5 µg mL −1 . Forced degradation of the bulk sample was conducted in accordance with the ICH guidelines. Acidic, basic, hydrolytic, oxidative, thermal, and photolytic degradations were used to assess the stability indicating power of the method. The drug was found to be stable in acidic, basic, thermal, hydrolytic, and photolytic stress conditions and showed slight degradation in oxidative stress condition.

Recent advances in electrochemical sensors and biosensors for monitoring drugs and metabolites in pharmaceutical and biological samples

“…The developed sensor shows good accuracy in both media (average recovery is 98.14 % in Dilosyn syrup and 97.4 % in human urine). The developed sensor has a low LOD of the order of 10 -8 mol l -1 in the range of 0.1-50 μmol l -1 compared to other methods such as visible spectrophotometry (3.23 μmol l -1 ) [ 27 ], ultra-high performance reversed phase chromatography (0.254 μmol l -1 ) [ 28 ] and spectrophotometric method (1.62 μmol l -1 ) [ 29 ].…”

Spectrophotometric Method for Simultaneous Determination of Amiloride and Hydrochlorothiazide in Combined Dosage Form

“…It is frequently used alone or in combination with other medications for the treatment of hypertension, congestive heart failure, symptomatic edema, diabetes insipidus, renal tubular acidosis, hypoparathyroidism, and edema and prevention of kidney stones and used in the treatment of osteoporosis [5]. Literature survey reveals that AML is estimated individually by UV [6] and combine with HCZ forced degradation studies [7], RP-HPLC, Derivative Spectrophotometry [8][9][10] and HCZ combine with other drugs HPLC [11], UV and HPLC [12], HPLC-UV, LC-DAD and LC-MS [13] UPLC RP-UPLC [14,15] methods were reported. The purpose of this study was to develop simple, rapid, precise and accurate UV method for the simultaneous estimation of AML and HCZ in pure and in combined tablet dosage form by Simultaneous equation method and validate as per International Conference on Harmonization (ICH) guidelines.…”