Development and Validation of a Stability Indicating Reverse Phasehigh Performance Liquid Chromatography Method for Simultaneous Determination of Clindamycin, Metronidazole, and Clotrimazole in Pharmaceutical Combined Dosage Forms

Abstract

Objective: The objective of present work was to develop and validate a simple, fast, precise, selective, and accurate reverse phase high-performance liquid chromatography method for the simultaneous determination of Clindamycine, Metronidazole and Clotrimazole in a pharmaceutical dosage form. Methods:The separation of these three drugs was achieved on ODS 250×4.6 mm, 5 mm C 18 column. Mobile phase containing 0.1% ortho phosphoric acid buffer and acetonitrile in the ratio of 55:45 v/v was pumped through column at a flow rate of 1 ml/minute. Temperature was maintained at 30°C and ultraviolet detection at 238 nm. Results:The retention times were observed to be 2.591, 3.584, and 4.221 minutes for Clindamycine, Metronidazole, and Clotrimazole, respectively. Linearity was found to be 25-150 μg/ml Clindamycine, Metronidazole, and Clotrimazole, respectively. The method was statistically validated for linearity, recovery, the limit of detection (LOD), limit of quantification (LOQ), accuracy, and precision. The stress testing of the drugs individually and their mixture are carried out under acidic, alkaline, oxidation, photostability, and thermal degradation conditions and its degradation products are well resolved from the analyte peaks. Conclusion:This method was successfully validated for accuracy, precision, and linearity, LOD, and LOQ.

Simultaneous Reverse-Phase Ultra Performance Liquid Chromatography Method Development and Validation for Estimation of Grazoprevir and Elbasvir

“…The accuracy of an analytical method expresses the nearness between the reference value and found value. The accuracy of the method was measured in triplicate at three concentration levels, i.e., 50%, 100%, and 150% of standard solutions of grazoprevir and elbasvir [12][13][14].…”

Mean Centering of Ratio Spectra Method for the Analysis of Theophylline and Ephedrine HCL Mixture in Tablet

“…Various studies have been published for the simultaneous determination of two or more components in a pharmaceutical combined dosage form by instrument method among others clindamycin, metronidazole, and clotrimazole in reverse-phase high-performance liquid chromatography method; vilanterol and fluticasone furoate by simultaneous equation method and a first-order derivative spectrophotometric method; atovaquone and proguanil by spectrophotometric derivatives methods; and duloxetine hydrochloride and methylcobalamin with the HPTLC method [4][5][6][7]. Some researchers have determined THEO and EPH in tablets using derivative ratio spectrum method, HPLC, and zerocrossing derivative [8][9][10].…”