Simultaneous Estimation of Atorvastatin Calcium, Ramipril and Aspirin in Capsule Dosage Form by RP-LC

A simple, sensitive, precise and accurate reversed phase liquid chromatographic method has been developed for the simultaneous estimation of atorvastatin (AT) calcium, ramipril (RA) and aspirin (AS) from capsule dosage form. The method was developed using a Phenomenex Luna C₁₈ (250 mm, 4.6 mm i.d., 5 µm) column with a mobile phase consisting of 0.1%, orthophosphoric acid buffer:acetonitrile:methanol (45:50:5 v/v/v), pH 3.3, at a flow rate of 1 mL min^?1. Detection was carried out with ultra-violet detection at 210 nm. The retention times were about 12.19, 2.35, and 3.95 min for AT calcium, RA and AS, respectively. The developed method was validated for linearity, accuracy, precision, limit of detection, limit of quantitation and robustness. The linearity ranges were 1–6 µg mL^?1 for AT calcium, 0.5–3 µg mL^?1 for RA and 7.5–45 µg mL^?1 for AS with mean recoveries of 100.59 ± 0.68, 100.62 ± 0.83 and 100.49 ± 0.73% for AT calcium, RA and AS, respectively. Limit of detection obtained were 29.85 ng mL^?1 for AT calcium, 4.71 ng mL^?1 for RA and 85.13 ng mL^?1 for AS. Impurity of salicylic acid was found in capsule dosage form at the retention time of about 4.84 min. The proposed method can be used for the estimation of these drugs in combined dosage forms.     

Validated HPTLC Method for Simultaneous Analysis of Alfuzosin Hydrochloride and Dutasteride in a Pharmaceutical Dosage Form

JPC – Journal of Planar Chromatography – Modern TLC - A sensitive, simple, selective, precise, and accurate HPTLC method for analysis of alfuzosin hydrochloride (ALF) and dutasteride...     

A Stability-Indicating LC Method for the Simultaneous Determination of Telmisartan and Ramipril in Dosage Form

A simple, rapid, and precise method is developed for the quantitative simultaneous estimation of telmisartan and ramipril in combined pharmaceutical dosage form. A chromatographic separation of the two drugs was achieved with an ACE 5 C₁₈, 25-cm analytical column using buffer–acetonitrile (55:45 v/v). The buffer used in mobile phase contains 0.1 M sodium perchlorate monohydrate in double distilled water pH adjusted 3.0 with trifluoroacetic acid. The instrumental settings are flow rate of 1.5 mL min⁻¹, column temperature at 30 °C, and detector wavelength of 215 nm using a photodiode array detector. The resolution between ramipril and telmisartan were found to be more than 5. Theoretical plates for ramipril and telmisartan were 13,022 and 6,629. Tailing factor for ramipril and telmisartan was 0.94 and 0.98. Telmisartan, ramipril and their combination drug product were exposed to thermal, photolytic, hydrolytic and oxidative stress conditions, and the stressed samples were analysed by the proposed method. Peak homogeneity data of telmisartan and ramipril is obtained using photodiode array detector, in the stressed sample chromatograms, demonstrated the specificity of the method for their estimation in presence of degradants. The described method shows excellent linearity over a range of 20–400 μg mL⁻¹ for telmisartan and 2.5–50 μg mL⁻¹ for ramipril. The correlation coefficient for telmisartan and ramipril are 1. The relative standard deviation for six measurements in two sets of each drug in tablets was always less than 2%. The proposed method was found to be suitable and accurate for quantitative determination and the stability study of telmisartan and ramipril in pharmaceutical preparations.     

Densitometric HPTLC Method for Simultaneous Quantification of Sennosides A and B and Gallic Acid in a Pharmaceutical Dosage Form

JPC – Journal of Planar Chromatography – Modern TLC - A densitometric HPTLC method has been established for simultaneous quantification of sennosides A and B and gallic acid in a...     

Stability Indicating HPTLC and LC Determination of Dasatinib in Pharmaceutical Dosage Form

Two sensitive and reproducible methods are described for the quantitative determination of dasatinib in the presence of its degradation products. The first method was based on high performance thin layer chromatography (HPTLC) followed by densitometric measurements of their spots at 280 nm. The separation was on HPTLC aluminium sheets of silica gel 60 F₂₅₄ using toluene:chloroform (7.0:3.0, v/v). This system was found to give compact spots for dasatinib after development (R _F value of 0.23 ± 0.02). The second method was based on high performance liquid chromatography (HPLC) of the drug from its degradation products on reversed phase, PerfectSil column [C₁₈ (5 μm, 25 cm × 4.6 mm, i.d.)] at ambient temperature using mobile phase consisting of methanol:20 mM ammonium acetate with acetic acid (45:55, v/v) pH 3.0 and retention time (t _R = 8.23 ± 0.02 min). Both separation methods were validated as per the ICH guidelines. No chromatographic interference from the tablet excipients was found. Dasatinib was subjected to acid–alkali hydrolysis, oxidation, dry heat, wet heat and photo-degradation. The drug was susceptible to acid–alkali hydrolysis and oxidation. The drug was found to be stable in neutral, wet heat, dry heat and photo-degradation conditions. As the proposed analytical methods could effectively separate the drug from its degradation products, they can be employed as stability indicating.     

Determination and Quantification of Pitavastatin Calcium in Tablet Dosage Formulation by HPTLC Method

Abstract

A simple, sensitive, reliable, and rapid HPTLC method has been developed for the determination of pitavastatin calcium in tablet dosage form. Identification and determination were performed on aluminum backed silica gel 60F₂₅₄ washed with methanol. The mobile phase of ethyl acetate‐methanol‐ammonia‐1 drop formic acid (7:2:0.8) calibration plots were established showing the dependence of response (peak area) on the amount chromatographed. The spot were scanned at 245 nm. The method has a linear range of 50–250 ng/spot. The method was validated for selectivity, repeatability, and accuracy. The method was used for determination of the compound in commercial pharmaceutical dosage forms. It is a more effective option than other chromatographic techniques in routine quality control.     

Stability-Indicating HPTLC Method for the Determination of Atorvastatin and Ezetimibe: Application to Pharmaceutical Dosage Forms

JPC – Journal of Planar Chromatography – Modern TLC -     

Stability-Indicating HPTLC Analysis of Flurbiprofen in Pharmaceutical Dosage Forms

JPC – Journal of Planar Chromatography – Modern TLC - A sensitive, selective, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been...     

Simultaneous Densitometric TLC Analysis of Olmesartan Medoxomil and Hydrochlorothiazide in the Tablet Dosage Form

JPC – Journal of Planar Chromatography – Modern TLC - A simple, rapid, and selective densitometric thin-layer chromatographic (TLC) method has been established and validated for...     

HPTLC Determination of Atorvastatin in Plasma

High performance liquid chromatography has been the most popular choice for the determination of atorvastatin. In this study, two-step isocratic chromatography on silica gel 60F254 HPTLC layer and densitometric quantitation at λ = 280 nm was developed for the separation of atorvastatin from plasma constituencies and sodium diclofenac as peak-tracer. The established HPTLC method was validated in terms of LOD/LOQ, linearity, recovery and repeatability. The calibration function of the analyte was linear in the range 101–353.5 ng zone^?1 and the correlation coefficient was 0.9969. The limits of detection and quantitation were 30.3 and 101 ng zone^?1. The recovery and relative standard deviation obtained from between-days analysis were 97.5–103.0 and 1.7–3.4%.     

A Validated Stability-Indicating HPTLC Method for the Estimation of Gemcitabine HCI in its Dosage Form

JPC – Journal of Planar Chromatography – Modern TLC - Gemcitabine belongs to a class of drugs known as antimetabolites (pyrimidine analog) used in various carcinomas, such as pancreatic...     

Stability-Indicating HPTLC Method for Simultaneous Estimation of Amlodipine Besylate,Hydrochlorothiazide and Olmesartan Medoxomil in Combined Tablet Dosage Forms

JPC – Journal of Planar Chromatography – Modern TLC -     

Simultaneous Densitometric TLC Analysis of Atorvastatin Calcium and Fenofibrate in the Bulk Drug and in Pharmaceutical Formulations

JPC – Journal of Planar Chromatography – Modern TLC - The combination of atorvastatin calcium and fenofibrate is used for treatment of atherosclerotic vascular diseases. A simple,...     

Simultaneous Determination of Etodolac and Acetaminophen in Tablet Dosage Form by RP-LC

A simple, specific, precise and accurate reverse phase liquid chromatographic (RP-LC) method has been developed for the simultaneous determination of etodolac and acetaminophen in tablet dosage form. The chromatographic separation was achieved on a BDS Hypersil C18, 100 mm × 4.6 mm, 5 μm column at a detector wavelength of 274 nm using an isocratic mobile phase consisting of a mixture of 0.05% aqueous orthophosphoric acid and acetonitrile in the ratio of 50:50 (v/v) at a flow rate of 1.0 mL min^?1. The retention times for etodolac and acetaminophen were found to be 1.32 and 4.24 min, respectively. The method was validated for the parameters like specificity, linearity, precision, accuracy and robustness. The method was found to be specific and stability indicating as no interfering peaks of impurities, degradent and excipients were observed. The square of correlation coefficients (R ²) for etodolac and acetaminophen were 0.9996 and 0.9998 while percentage recoveries were 101.32 and 100.94%, respectively. Intra- and inter-day relative standard deviations for both the components were <2.0%. The proposed RP-LC method can be applied for the routine analysis of commercially available formulations of these drugs either as such or in combination.     

Simultaneous RP-HPTLC Method for Determination of Levodopa,Carbidopa, and Entacapone in Combined Tablet Dosage Form

JPC – Journal of Planar Chromatography – Modern TLC - A simple, rapid, specific, and accurate reverse-phase high-performance thin-layer chromatography (RP-HPTLC) method was developed...     

Simultaneous Determination of Prazosin,Atorvastatin, Rosuvastatin and Simvastatin in API,Dosage Formulations and Human Serum by RP‐HPLC

Prazosin hydrochloride is the first developed selective antagonist for α₁ — adrenoceptors, which is used as antihypertensive agent. Statins are used in the treatment of various types of hypercholesterolemia. In the present paper a simple, specific an accurate RP‐HPLC method was developed and validated for the simultaneous determination of prazosin, atorvastatin, rosuvastatin and simvastatin in active and in dosage formulations. A nucleosil 100‐10, C‐18, 10μ column having 250 × 4.6 mm i.d. in isocratic mode, with mobile phase containing methanol:water:acetonitrile (70:20:10) adjusted to pH 2.5 ± 0.02 using orthophosphoric acid. The flow rate was 1 mLmin^?1 and effluents were monitored at 240 nm. The % recovery for all the drugs in formulations was found to be 94‐105%. The parameters such as accuracy (%RSD less than 2), precision (%RSD less than 2), linearity (>0.999) were found to be satisfactory. The presented method was applied without any interference of excepients for the determination of tablets. The proposed method due to its low LOQ, excellent accuracy, precision and selectivity could be used for routine quality control.     

A Validated HPTLC Method for Simultaneous Analysis of Eugenol and Piperine in a Siddha Formulation

JPC – Journal of Planar Chromatography – Modern TLC - A high-performance thin-layer chromatographic (HPTLC) method has been established for simultaneous analysis of eugenol and piperine...     

Simultaneous HPTLC Determination of Clotrimazole and Tinidazole in a Pharmaceutical Formulation

JPC – Journal of Planar Chromatography – Modern TLC - An HPTLC method for simultaneous determination of clotrimazole and tinidazole in a pharmaceutical formulation has been developed...     

Simultaneous Determination of Diclofenac Sodium and Rabeprazole Sodium in Bulk and Pharmaceutical Dosage Form by LC

A simple, selective, rapid, precise and accurate reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of diclofenac sodium and rabeprazole sodium from pharmaceutical formulations. The method was developed using a HiQ SiL C18 (250 mm × 4.6 mm i.d.) column with a mobile phase consisting of methanol:water, (80:20 v/v), at a flow rate of 1.25 mL min⁻¹. Detection was carried out at 284 nm. Indapamide was used as an internal standard. The developed method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation. The proposed method can be used for the estimation of these drugs in combined dosage forms.

     

Simultaneous Determination of Diclofenac Sodium and Rabeprazole Sodium in Bulk and Pharmaceutical Dosage Form by LC

A simple, selective, rapid, precise and accurate reverse phase high pressure liquid chromatographic method has been developed for the simultaneous estimation of diclofenac sodium and rabeprazole sodium from pharmaceutical formulations. The method was developed using a HiQ SiL C18 (250 mm × 4.6 mm i.d.) column with a mobile phase consisting of methanol:water, (80:20 v/v), at a flow rate of 1.25 mL min^?1. Detection was carried out at 284 nm. Indapamide was used as an internal standard. The developed method was validated for linearity, accuracy, precision, limit of detection and limit of quantitation. The proposed method can be used for the estimation of these drugs in combined dosage forms.