Development and Validation of a Stability-Indicating LC Method for the Simultaneous Estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine Impurities

Abstract

A simple, fast, and efficient RP-HPLC method has been developed and validated for the simultaneous estimation of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and the quantification of Levodropropizine impurities in the Reswas syrup dosage form. A gradient elution method was used for the separation of all the actives and Levodropropizine impurities by using the X-Bridge C18, 150 mm × 4.6 mm, 3.5 μm column with a flow rate of 1.0 mL/min and detector wavelength at 223 nm. The mobile phase consisted of a potassium dihydrogen orthophosphate buffer and acetonitrile. All the peaks were symmetrical and well-resolved (resolution was greater than 2.5 for any pair of components) with a shorter run time. The limit of detection for Levodropropizine and its Impurity B was 0.07 μg/ml & 0.05 μg/ml, whereas the limit of quantification was 0.19 μg/ml & 0.15 μg/ml respectively. The method was validated in terms of precision, accuracy, linearity, robustness, and specificity. Degradation products resulting from the stress studies were well-resolved and did not interfere with the detection of Levodropropizine, Chloropheniramine, Methylparaben, Propylparaben, and Levodropropizine Impurity B, thus the test method is stability-indicating. Validation of the method was carried out as per International Conference on Harmonization (ICH) guidelines.

A novel RP‐HPLC refractive index detector method development and validation for determination of trace‐level alcohols (un‐sulfated) in sodium lauryl sulfate raw material

“…The proposed method was validated as per International Conference on Harmonization guidelines and US Pharmacopeia (USP) Compendia (Horacio et al, 2018; ICH, 2005; Dongala, Katakam, et al, 2019; Dongala, Katari, et al, 2019a, 2019b; Ashok, Thirupathi, Ravindra Kumar, & Jayashree, 2017; Murthy, Srinivas, Kumar, & Mukkanti, 2011; Subramanian, Katari, Dongala, & Jonnalagadda, 2020; Palakurthi, Dongala, Yalavarthi, & Anireddy, 2019; Kumar et al, 2013a, 2013b; Dongala, Katakam, et al, 2019; Dongala & Palakurthi, 2019; Dongala, Palakurthi, et al, 2019) based on the industry standard equipment.…”

A simple alternative and improved HPLC method for the estimation of doravirine, lamivudine, and tenofovir disoproxil fumarate in solid oral dosage form

“…Forced degradation studies were conducted and all the parameters for doravirine, lamivudine, and tenofovir disoproxil fumarate were within the limits. Doravirine, lamivudine, and tenofovir disoproxil fumarate have shown significant sensitivity under acid, alkali, peroxide (Umamaheshwar et al, 2021), and thermal conditions (Krishna Rao et al, 2020;Kumar et al, 2013;Kumar et al, 2017;Subramanian et al, 2020). These drugs gradually undergo degradation with time and prominent degradation was observed.…”

A simple high‐performance liquid chromatography method development for Carbidopa and Levodopa impurities: Evaluation of risk assessment before method validation by Quality by Design approach

“…In the current study, we have proposed an improved and alternative quality by design-based RP-HPLC method for the simultaneous determination of carbidopa, levodopa, and their impurities with a combination of entacapone in solid oral dosage forms. The purpose of the stabilityindicating analytical method is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of various environmental factors such as temperature, humidity, and light, and to establish a retest period for the drug substance or shelf life for the drug product and recommended storage condition [17][18][19][20]. Dongala et al [21] have demonstrated the importance of stability-indicating in the pharmaceutical industry.…”